Devices and methods for vascular navigation, assessment and/or diagnosis

ABSTRACT

Devices and methods for vascular navigation, assessment and/or diagnosis are described which determine the location of the tip of a vascular catheter using the introduction of a medium with a measurable parameter (e.g., temperature, light reflection, sound reflection, etc.) and sensing and measuring the measurable parameter as the catheter is advanced. Measurements of the parameter are tracked over time, recorded and analyzed. The value of the parameter and/or the shape of the parameter value vs. time curve may be used in the analysis. For example, curve amplitude, variability, standard deviation, slope, etc. may be used in the analysis of catheter location.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of PCT/US2017/038374 filed Jun. 20,2017, which claims the benefit of priority to U.S. ProvisionalApplication No. 62/356,383 filed Jun. 29, 2016, U.S. ProvisionalApplication No. 62/405,879 filed Oct. 8, 2016 and U.S. ProvisionalApplication No. 62/444,941 filed Jan. 11, 2017, each of which isincorporated herein by reference in its entirety.

FIELD OF THE INVENTION

The present invention relates to devices and methods for vascularnavigation, assessment, and/or diagnosis.

INCORPORATION BY REFERENCE

All publications and patent applications mentioned in this specificationare herein incorporated by reference to the same extent as if each suchindividual publication or patent application were specifically andindividually indicated to be so incorporated by reference.

BACKGROUND OF THE INVENTION

A central vascular catheter (vascular catheter), also known as centralline, central venous line or central venous access catheter, is acatheter placed into a large vein in the neck (internal jugular vein),chest (subclavian vein or axillary vein) or groin (femoral vein). It isprimarily used to administer medication or fluids, obtain blood tests(such as central venous oxygen saturation), and measure central venouspressure.

A peripherally inserted central catheter (PICC or PIC line) is a form ofvascular catheter that can be used for a prolonged period of time and/orfor administration of substances. It is a catheter that enters the bodythrough the skin (percutaneously) at a peripheral site, extends to thesuperior vena cava (a central venous trunk), and may remain in place fordays or weeks.

Placing the catheter (PICC, central vascular catheter or relatedvascular catheter, referred to herein as “vascular catheter”) in theideal location can be challenging. The catheter may be mistakenlyinserted into an artery instead of a vein, or into the incorrect vein orincorrect venous branch or advanced too far or into/along a vessel wall.Ideally, the catheter tip is placed in the superior venacava/cavo-atrial junction (SVC-CAJ).

Correct placement currently is determined by taking a physicalmeasurement of the distance from the catheter entry point to theestimated location of the lower one third of the superior vena cava.There are several challenges with current techniques. First, thecatheter may enter into an artery instead of a vein. Second, a cathetermay be advanced down the incorrect branch of the vein tree. The cathetermay advance down an azygous vein, a thoracic vein, a jugular vein, orany number of additional veins on the branch. Third, a catheter may beadvanced past the superior vena cava and into the heart or into theinferior vena cava. This can be a dangerous situation. Fourth, acatheter may advance up against, or embed in, a vessel wall which canprevent fluid delivery or fluid draw. Fifth, because the gold standardfor catheter placement is essentially blind, placement verificationneeds to be confirmed with a chest x-ray which is substantiallyadditional cost and time. Sixth, the estimated distance to the lower onethird of the superior vena cava may be inaccurate.

There is a need for a relatively easy and accurate way of navigating avascular catheter by accurately identifying the location of the tip ofthe catheter as it is advanced to its targeted location.

SUMMARY OF THE INVENTION

The present invention includes vascular catheter location and navigationdevices and methods which determine the location of the tip of avascular catheter using the introduction of a medium with a measurableparameter (e.g., temperature, light reflection, sound reflection, etc.)and sensing and measuring the measurable parameter as the catheter isadvanced. Measurements of the parameter are tracked over time, recordedand analyzed. The value of the parameter and/or the shape of theparameter value vs. time curve may be used in the analysis. For example,curve amplitude, variability, standard deviation, slope, etc. may beused in the analysis of catheter location.

In one variation, the location detection system may generally comprisean elongate body; a conduit defining one or more flow passages, whereeach of the one or more flow passages has a distal end and where theconduit is configured to secure a position of the elongate body relativeto the conduit; a sensor positioned at or in proximity to the distal endof the elongate body, wherein the conduit maintains a fixed distancebetween the sensor and the one or more flow passage distal ends, andwherein the sensor is configured to measure at least one parameter of afluid after the fluid is emitted from the one or more flow passagedistal ends; and a controller in communication with the sensor, whereinthe controller is configured to determine a time-derived function of theat least one parameter of the fluid and is further configured to obtaina position of the sensor within a body of a subject.

In one variation for a method of determining a location within a body ofa subject, the method may generally comprise positioning an elongatebody within a lumen of a catheter; positioning the catheter within thebody of the subject; introducing a fluid through the lumen and one ormore flow passages of a conduit into the body; measuring via a sensor atleast one parameter of the fluid after introduction within the body ofthe subject, wherein the sensor is positioned at or in proximity to adistal end of the elongate body such that the sensor is maintained at afixed distance relative to a fluid exit port of the catheter or conduit;determining a time-derived function of the at least one parameter of thefluid; and determining a position of the sensor within the body of thesubject based upon the time-derived function.

In yet another variation, the location detection system for use within acatheter lumen may generally comprise an elongate body; a sensorpositioned at or in proximity to the distal end of the elongate body,wherein the sensor is configured to measure at least one parameter of afluid after the fluid is emitted from the catheter lumen; and acontroller in communication with the sensor, wherein the controller isconfigured to determine a time-derived function of the at least oneparameter of the fluid and is further configured to obtain a position ofthe sensor within a body of a subject.

Flow direction, characteristics, profiles, and types, with respect tothe catheter and catheter tip can provide a vast array of information oncatheter positioning during placement, after initial or subsequentplacement, after the catheter has been in place for a period of time,and/or during withdrawal.

Devices and methods disclosed herein can be used to inform the user ofone or more of the following conditions: insertion, placement oradvancement of the catheter into an artery rather than a vein;insertion, placement or advancement of the catheter into an undesiredvein branch; placement or advancement of the catheter too near, into, orpast the heart; or placement of the catheter tip up against, or embeddedin, a wall of a vessel. Each of these scenarios is described in detailherein.

Blood Flow characteristics and direction can help determine if thecatheter is in an artery or a vein. In the case of a vein, the bloodwill generally be flowing more slowly toward the heart, while with theartery the blood will generally be flowing more quickly away from theheart. At least the blood flow direction and speed with respect to thecatheter will be different depending on whether the catheter is in anartery or vein. Other flow parameters may also be different (turbulence,pulsatility, etc.). In addition, the flow characteristics of bloodwithin a smaller branch of the blood vessel will be different than theflow characteristics in a larger vessel. For example, blood flow withina vein branch may completely or substantially stop where a catheter tipis totally or partially occluding the vein branch. In the case where thecatheter tip is seated against a vessel wall, flow patterns around thecatheter are different than when the catheter tip is in free flowingblood.

In the situation where the catheter tip passes into the superior venacava, and passes near or into the heart's right atrium or rightventricle, the flow characteristics of the blood will change. Forexample, the blood flow may become more or less turbulent. More or lessturbulence results in different flow characteristics, profiles, and flowtypes and can be detected by a variety of types of sensors.

These flow profile changes can be measured using devices and methodsdisclosed herein.

Devices disclosed herein may include a catheter, a guidewire, a stylet,a controller, communications, an infusion mechanism, a medium source,medium sensor or sensors etc.

Devices and methods disclosed herein utilize the introduction of amedium (saline, fluid, light, sound, etc.) which has a measurableparameter (temperature, opacity, light reflectivity, sound reflectivity,density, viscosity, ability to absorb light, ability to absorb sound,amplitude, etc.) where the measurable parameter can be detected using asensor (temperature sensor, thermocouple, light sensor, sound sensor,microphone, etc.). By introducing a medium at or near the tip of thecatheter, and measuring one or more parameters of the medium over time,and possibly over distance, flow parameters, such as flow direction,rate, volume and type, turbulent or laminar, can be determined. Based onthese determinations, the user can identify whether the catheter tip isprogressing to the desired position in the vasculature via the desiredpath. Vessels may be identified by type (vein vs. artery, vs heartetc.), size, shape, etc.

The medium may be injected or introduced in boluses or drips,periodically during all or part of catheter placement, continuallyduring all or part of catheter placement, or at regular intervals duringall or part of catheter placement. The medium may be introducedmanually, or automatically via a controller, or automatically via anintravenous (IV) bag with or without an IV pump, or passively with anIV.

Measurements of one or more medium parameters may be taken before,during and/or after medium introduction. For example, room temperatureor other non-body temperature saline (or other fluid) may be injectedthrough the catheter or stylet during placement. One or more sensors ator near the distal tip of the catheter/stylet can measure thetemperature of the fluid immediately surrounding the sensor(s) overtime. Based on blood flow characteristics, including direction,pulsatility and turbulence, the temperature profile over time will bedifferent at different locations, resulting in a temperature (orparameter) profile or signature for different flow types and thereforedifferent catheter/stylet tip location scenarios.

Temperature sensors may include thermocouples or other temperaturesensors, such as, fiber optic, resistive, bimetallic, thermometer,state-change, silicon diode, thermistors, optical temperaturemeasurement (infrared or otherwise), mercury thermometers, manometers,etc. The sensor or sensors is/are in communication with a controllerwhich records and/or analyzes the signal from the sensor(s). Thecommunication between the sensor and the controller may be wired orwireless.

By placing a thermocouple, thermistor, or other temperature sensingdevice, or an array of temperature sensing devices on or through thecatheter, one can determine the direction of flow of a room temperaturefluid bolus that is injected into the blood stream. Since bloodtemperature is around 37 degrees C., a saline (or other) fluid bolus orfluid infusion with a temperature around 20-25 degrees C. or between 15and 30 degrees C. or between 0 and 35 degrees C., or generally coolerthan 37 degrees C. is distinguishable from body temperature and can beused to detect blood flow direction and characteristics, and therefore,device location.

In some embodiments, optical sensing can be used. Optical sensors can beused to detect the direction of flow by measuring the amount of dilutionof blood with another fluid with different optical characteristics, suchas saline.

Sonar or sound can alternatively be used as the parameter to detectblood flow direction, velocity and other blood flow characteristics.Sound waves may be produced by the controller and conveyed to the tip,or near the tip, of the catheter. A sound detector, or microphone,records the sound waves reflected back by the red blood cells or othercomponents of blood. Saline may also be introduced to create a change inthe sound waves detected.

Various mediums and/or parameters may be used in combination in someembodiments. For example, light (visible and/or not visible) andtemperature may both be used. In addition, other sensors may be used toaid in locating the catheter, including electro cardiogram (ECG).Pressure, as disclosed in U.S. provisional patent application 62/492,739filed on May 1, 2017, and incorporated herein in its entirety byreference, may also be used in combination with these embodiments.

Embodiments that incorporate more than one type of sensor may be usedeither in each situation (vein vs. artery, vessel branch, vessel wall,catheter in heart or past heart), or different sensors may be used indifferent situations. For example, pressure may be used to determinewhen the catheter tip is in the heart, where temperature may be used todetermine whether the catheter is in an artery. Or, for example, ECG canbe used to determine if the catheter is in the cavo-atrial junction buttemperature can be used to determine if the catheter has gone down anazygous or unintended vein branch.

In some embodiments, a camera may be used to optically determine thepresence, and possibly the density, or number, of red blood cells. If agreater number of cells pass by, then the flow is stronger. If they areflowing in the opposite direction, then the flow has reversed direction,thus the catheter is proceeding in the incorrect direction.

These sensing modalities can also be combined with one or more (ECG)sensors to detect catheter placement. ECG electrodes can be placedprecisely either at the target location of the catheter tip (forexample, in the superior ⅓ of the vena cava), or over the heart itselfto detect an unnecessary over extension of the catheter. Alternatively,one or more ECG sensors may be incorporated into the device itself, forexample, into a guidewire/stylet.

In any of the embodiments disclosed herein, the sensors may be locatedat or near the tip of, or along the length of a guidewire or stylet thatpasses through a vascular catheter.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows an embodiment of the vascular catheter navigation devicenavigating the human anatomy.

FIG. 2 shows an embodiment of the vascular catheter navigation deviceplaced in the human anatomy.

FIG. 3 shows an embodiment of the vascular catheter navigation device.

FIG. 4 shows the influence of fluid flow direction on flow behavior ofan injected fluid bolus with respect to the catheter tip before, duringand after injection.

FIGS. 5A-5E show a variety of embodiments of the vascular catheternavigation device.

FIGS. 6A-6E show a variety of embodiments of the vascular catheternavigation device.

FIG. 7A shows temperature vs time data in various locations of thevasculature of a pig.

FIGS. 7B and 7C show temperature vs. time curves for varying embodimentsof the vascular catheter navigation device.

FIG. 8 is a schematic illustration showing fluid flow in different areasof the vascular system.

FIGS. 9A-9E show various embodiments of the vascular catheter navigationdevice.

FIGS. 9F-9J show distances between the fluid ports and the temperaturesensors.

FIG. 10 shows an embodiment of the vascular catheter navigation devicewhich can be used with any catheter.

FIGS. 11A-I show various views of various embodiments of astylet/guidewire version of the vascular catheter navigation device.

FIGS. 12-17 show various embodiments of the vascular catheter navigationdevice.

FIGS. 18A and B show 2 possible embodiments for a flow director.

FIGS. 19A-C show other embodiments of the vascular catheter navigationdevice injectate lumens.

FIG. 20 shows an embodiment of the vascular catheter navigation device.

FIG. 21 shows features that enhances a controlled turbulent flow.

FIG. 22 shows features that create a controlled laminar (or lessturbulent) flow.

FIGS. 23A-E and 24A-E show possible graphical user interfaces of thedevice.

FIGS. 25A-C show embodiments of the vascular catheter navigation devicewhich include a conduit to control fluid flow exiting from the device.

FIG. 26 shows an embodiment of the vascular catheter navigation devicewhere the flow passage is within the guidewire/stylet component itself.

FIG. 27 shows a variation of the conduit which includes a proximalflange.

FIG. 28 shows a variation of the embodiment shown in FIG. 27 where theconduit has both a proximal flange and a distal flange.

FIGS. 29A-C show an embodiment of the vascular catheter navigationdevice where the conduit includes a thin-walled inflatable structure.

FIG. 30 shows an embodiment which includes a thin-walled “skirt”.

FIGS. 31-33 show embodiments where the conduit includes feature(s) tohelp direct the fluid flow exiting the conduit.

FIG. 34 shows an embodiment with a deflector.

FIG. 35 shows an embodiment of the conduit which is conical shaped.

FIGS. 36A-C show an embodiment of the vascular catheter navigationdevice which includes a compressible conduit.

FIGS. 37A-F show 2 different cross-sectional views of variousembodiments of the vascular catheter navigation device.

FIGS. 38A-E show various embodiments of the vascular catheter navigationdevice.

FIGS. 39A-D are longitudinal cross sectional views of embodiments of thevascular catheter navigation device.

FIGS. 39E-G are radial cross sectional views of embodiments of thevascular catheter navigation device.

FIGS. 39H-J are cross sectional views of embodiments of the vascularcatheter navigation device with securing type conduits.

FIGS. 40A-C show different configurations of vascular catheter lumensand variations of embodiments of the vascular catheter navigation devicewhich work with them.

FIGS. 41A-F show various embodiments of a guidewire/stylet component ofthe vascular catheter navigation device.

FIGS. 42A-C show an embodiment of the vascular catheter navigationdevice.

FIG. 43 shows an embodiment of the vascular catheter navigation devicewhich uses optical reflection.

FIG. 44 shows an embodiment of the vascular catheter navigation devicewhich uses optical reflection.

FIGS. 45 and 46 show temperature profiles in the superior vena cava andin the heart.

FIG. 47 shows an embodiment which uses sonar and sound waves to detectblood direction.

FIGS. 48 and 49 show an embodiment which uses one or more pressuresensors, with the aid of a turbulence inducer, to determinedirectionality of flow.

FIG. 50 shows an embodiment which includes a controller and a mediumintroduction mechanism.

FIG. 51 shows an embodiment which includes an automated injection systemfor the cartridge/syringe/reservoir which may be a motor driving leadscrew.

FIG. 52 is a block diagram of a data processing system, which may beused with any embodiments of the invention.

DETAILED DESCRIPTION OF THE INVENTION

FIG. 1 shows an embodiment of the vascular catheter navigation device orsystem navigating the human anatomy. Vascular catheter navigation device102 is shown in vein 104 of a patient. The vascular catheter navigationdevice has been inserted into the patient via insertion point 106. Theinsertion point is shown here in the patient's chest, however theinsertion point may alternatively be the patients leg, arm or neck orother location. To navigate a standard vascular catheter into itsdesired location, several undesirable obstacles need to be avoidedand/or overcome. For example, a vascular catheter may be mistakenlyplaced into an artery instead of a vein, a vascular catheter may venturedown or up an incorrect branch of the vascular system, a vascularcatheter may become lodged against a wall of a blood vessel, a vascularcatheter may be advanced too far, either too close to the heart, intothe heart or past the heart, or a vascular catheter may not be advancedfar enough to reach its desired location, or may migrate to a lessdesirable location. A few of these hazard areas are labeled 116. Distaltip of vascular catheter navigation device is shown as 108. At theproximal end of vascular catheter navigation device is shown infusion orsampling lumen 110 which is in fluid communication with opening oropenings at or near the distal end of vascular catheter navigationdevice, and sensing port 112 which is in communication with controller114. Sensing port 112 is in communication with one or more sensors (notshown here) at or near distal tip 108 of vascular catheter navigationdevice 102. Although one infusion/sampling lumen and one sensing portare shown here, multiple infusion/sampling and/or sensing ports mayexist. Infusion lumen 110 may also be in communication with controller114.

FIG. 2 shows an embodiment of the vascular catheter navigation devicewhere the distal tip is placed in the superior vena cava/cavo-atrialjunction (SVC-CAJ) 202.

FIG. 3 shows an embodiment of the vascular catheter navigation device.The distal end of the vascular catheter navigation device is insertedinto the appropriate access vein, and advanced along the vein to itstarget location. After the vascular catheter navigation device isinserted into the blood vessel, generally through a needle, or sheath,sensing element 302 senses a parameter within the blood vessel. Amedium, such as fluid, with a measurable parameter, such as temperature,is injected through the device, and into the blood vessel. The sensorsignals are communicated back to the controller where the sensorsignal(s) are analyzed based on the sensor data over time, includingdata curve slope, magnitude, value, length, variability, standarddeviation, shape, etc. For example, the controller can determine whetherthe distal end of the vascular catheter navigation device is in anartery instead of a vein, based on magnitude and direction of blood flowaround the vascular catheter navigation device by measuring andanalyzing the measurable parameter. If the controller determines thatthe distal end of the vascular catheter navigation device is in anundesired position, an alert or other indicator may communicate with theuser. For example, if the controller determines that the catheter is inan artery instead of a vein, a specific identifying signal may sound,including an audible, visual signal etc., instructing the user to removethe vascular catheter navigation device, and any other device, such assheaths, catheters etc., and apply pressure to the blood vessel.

Similarly, the vascular catheter navigation device can sense when thedistal end is in the incorrect branch of a vein, based on flowdirection, and possibly flow profile and magnitude. When advancing thevascular catheter navigation device in the correct direction and in thecorrect vessel (toward the SVC-CAJ, in a vein), the blood flows over thevascular catheter navigation device from the more proximal end to thedistal end.

FIG. 3 shows one sensor 302, one sensor port 112 and oneinfusion/sampling lumen 110. However, more than one infusion/samplinglumen and/or more than one sensors may be present. In addition the portto the controller and the sampling lumen could be the same lumen and beincorporated into a single lumen catheter. The infusion and/or samplinglumen may also be connected to the controller.

FIG. 4 shows the influence of fluid flow direction on flow behavior withrespect to the catheter tip before, during and after an injected fluidbolus. At time=0, device 102 is in vessel 404. Device 102 includessensor 302. Sensor 302 is designed to measure a parameter of bloodand/or the injection medium. The controller (not shown) is incommunication with sensor 302 via connector 402 which, in this example,runs the length of the catheter back to the controller. Sensor 302 andconnector 402 may be incorporated into the vascular catheter or may beincorporated into a stylet that runs through the catheter. Medium 410 isintroduced into the vessel at time=x. For example, the medium may besaline at a temperature which is different than that of the body. Theparameter measured by the sensor in this example would be temperature.After the injection, at T=x+1, blood flow will carry the medium with theblood flow. Where blood flow 406 flows away from the catheter, the bolusof medium 404 travels away from the catheter tip and away from thesensor. Where blood flow 408 flows toward the catheter, the bolus ofmedium 410 travels toward and over the catheter tip. This example showsa bolus of fluid, but a stream of fluid may also be used.

Depending on the location of the sensor(s), different temperatureprofiles over time may be measured. Variables in flow rate, direction,turbulence, etc. will affect the mixing of blood and medium and affectthe profile of the parameter, in this example, temperature, over time.In this way, the system can determine direction of blood flow at or nearthe catheter tip.

FIGS. 5A-5E and 6A-6E show several example embodiments of the vascularcatheter navigation device. FIG. 5A shows an embodiment with sensor 302at the catheter tip. FIG. 5B shows an embodiment with the sensor near,but not at, the catheter tip. This configuration may prevent the sensorfrom measuring the parameter during introduction of the medium from thecatheter tip, allowing better distinction between flow directions. FIG.5C shows an embodiment with 2 sensors, one at the catheter tip, and onenear, but not at, the catheter tip. Sensor readings at differentpositions will vary based on fluid flow direction, characteristics,profile etc. A sensor near, but not at, the catheter tip may be fromabout 0.05 cm to about 2.0 cm back from the tip. Alternatively, a sensornear, but not at, the catheter tip may be from about 0.75 cm to about1.25 cm back from the tip. FIG. 5D shows an embodiment where a sensor ison guidewire or stylet 502. Stylet 502 may move freely within thecatheter allowing one or more sensors to be placed at a distance fromthe catheter tip. In addition, the guidewire/stylet may be removed aftercatheter placement. In this embodiment, the catheter may also include asensor, as shown here. FIG. 5E shows an embodiment with opening 504which is near, but not at, the catheter tip. This opening may be influid communication with a separate medium introduction lumen orinfusion lumen. This specific medium introduction lumen may exit at thecatheter tip. An opening near, but not at, the catheter tip may be fromabout 0.5 cm to about 2.0 cm back from the tip. Alternatively, anopening near, but not at, the catheter tip may be from about 0.75 cm toabout 1.25 cm back from the tip. The medium introduction lumen may be inthe catheter or may be within the stylet.

FIG. 6A shows an embodiment with an opening between two sensors, both ofwhich are near, but not at, the catheter tip. FIG. 6B shows anembodiment with more than one sensor near, but not at, the tip of thecatheter. FIG. 6C shows an embodiment with an opening between twosensors, one of which is at the catheter tip. FIG. 6D shows anembodiment which includes an opening proximal to 2 sensors. FIG. 6Eshows an embodiment with channel 602. Channel 602 allows fluid to flowwithin the catheter, in proximity to a sensor within the catheter.

It is apparent that numerous variations of these and other embodimentsof the vascular catheter navigation device are envisioned. For example,sensors, openings, channels etc. may be on different sides of thecatheter and/or guidewire/stylet. Sensors, openings and channels areshown here at or near the catheter tip, however, they may be locatedanywhere along the catheter and/or guidewire/stylet.

FIG. 7A shows temperature vs time data in various locations of thevasculature of a pig using one embodiment of the vascular catheternavigation device. The embodiment used to obtain this data had twotemperature sensors—a distal sensor (T1) which was closest to the tip ofthe device (so in this instance, closest to the heart), and a proximalsensor (T2). The temperature vs. time curve is shown for both sensorsfor 5 different locations within the vasculature, the superior venacava, the cavoatrial junction, the right atrium, the right ventricle,and the inferior vena cava. The first two locations, the superior venacava and the cavoatrial junction, represent correct placement of thevascular catheter navigation device. The other three locations representincorrect placement of the device. Note that the signatures of the rightthree temperature vs. time curves (representing incorrect placement) aredifferent than the first two curves (representing correct placement orclose to a correct placement). Also note that the right three curves arealso able to be differentiated from each other. Different sensorconfigurations will result in different curve signatures in differentvascular locations. For example, a single temperature sensor will give adifferent set of curves than will a system with 2 temperature sensors.The distance of the sensor(s) from the infusion exit site will alsoprovide different curves. Different infusion rates, infusion volumes,infusion types (bolus vs. stream), infusion pressures, infusionvelocities etc., will also provide different curves and thus differentanatomical signatures. Different aspects of the curves may be analyzedby the controller to determine vascular location. These may include, butare not limited to, slope, magnitude, value, length, variability,standard deviation, shape, area under the curve, Fourier transform,frequencies, harmonics, etc. In some embodiments, certain frequencies inthe data may be filtered out, including those relating to the heartbeat,system noise, etc.

In some embodiments there is one temperature sensor and therefore onetemperature vs. time curve. In some embodiments there are two or moretemperature sensors and therefore two or more temperature vs. timecurves. The graphs of 2 temperature sensors are shown in FIG. 7A. Insome embodiments, the infusion exit port is near the more proximaltemperature sensor or temperature sensors. In some embodiments theinfusion exit port is proximal or distal to the temperature sensor ortemperature sensors. In some embodiments the infusion exit port isbetween the temperature sensors. In some embodiments, one or more thantwo temperature sensors may be used.

FIGS. 7B and 7C show two alternative temperature vs. time curves. Notethat curves may appear different, in different anatomy, and based on thedesign of the vascular catheter navigation device. For example, thecurve may be different for different sensor locations with respect tothe fluid exit port. The curve may depend on the type of sensor or thefluid injection rate. The curve may depend on the initial temperature ofthe injection fluid. Other design factors may also result in differenttemperature vs. time curve shapes.

In addition, calibration of the temperature vs. time curves may beperformed by the controller. For example, a baseline measurement may bederived after insertion of the system, or at other points during use ofthe system. For example, a baseline measurement may be taken in theblood vessel before any injection fluid is injected, or at a particularinjection rate. An example of this is shown in FIG. 7B. “Baseline” dataare show in the graph where a temperature measurement was taken withoutany fluid injection through the system. This baseline measurement may beused in the controller's analysis of the data to determine the locationof the vascular catheter navigation device within the anatomy.

Various properties of the temperature vs. time curves may be analyzed todetermine the location of the vascular catheter navigation device. Forexample, curve amplitude, noise, standard deviation, shape, slope,value, area under the curve, Fourier transform, frequencies, harmonics,etc. of one or more curves may be used to determine the vascularcatheter navigation device location within the vasculature. These sameparameters may be compared between and among multiple temperature vs.time curves to determine vascular catheter navigation device placementlocation. For example, the location, relative location, magnitude,and/or relative magnitude of peaks (positive or negative) of the curvesmay be used to determine vascular catheter navigation device location.In addition, the difference between amplitude, noise, standarddeviation, shape, slope, value, area under the curve, and/or Fouriertransform, harmonics, frequencies of the data from the multipletemperature sensors may be used to determine vascular location.Depending on droplet size and/or infusion rate, an area under the curve,or Fourier transform may be used to analyze the temperature vs. timecurve and thus vascular location. Additionally, a maximum, or a numberof maxima, may be more relevant.

The term “droplet” used herein may mean a drop, a bolus, a stream, anintermittent stream, etc. when referring to the injectate.

FIG. 8 is a schematic showing fluid flow in different areas of thevascular system representing desired (correct) and undesired (incorrect)device placement. Arrows 802 show blood flow direction. Areas 804 showfluid (such as saline) infusion. Note how the different anatomicallocations will yield different flow conditions and thus differentdissipation patterns of the fluid infusion. Although 1 temperaturesensor 806 is shown here, two, or three, or four or five or six or moremay be used, in this, and any other embodiments disclosed herein.

FIGS. 9A-9E show various embodiments of the vascular catheter navigationdevice where two temperature sensors are on the guidewire/stylet. FIG.9A shows stylet 910 with proximal temperature sensor 902 and distaltemperature sensor 904. The injectate 906 in this embodiment exits atthe distal tip of catheter 908, proximal, or near to proximaltemperature sensor 902. Alternatively, the injectate may be injectedthrough a lumen of the guidewire/stylet. Although 2 sensors are shownhere, one, or more than 2 may be used.

FIG. 9B shows an embodiment where the injectate is injected through thestylet/guidewire and exits between the two temperature sensors. FIG. 9Cshows an embodiment where the injectate is injected through thestylet/guidewire and exits near or distal to the distal temperaturesensor. If one temperature sensor is used, the fluid injection exit portmay be either proximal to, or distal to the sensor.

FIGS. 9D and 9E show an embodiment with two temperature sensors on thestylet/guidewire where the guidewire is able to be moved with respect tothe end of the catheter. This embodiment may be used to alter thesensing and/or injectate exit location with respect to the tip of thecatheter.

For example, in some embodiments, the stylet/guidewire may include boththe injection lumen (i.e. the stylet/guidewire may be hollow) and atemperature sensor so that it may be positioned in the anatomy firstand/or independently of the vascular catheter. For example when jugularaccess is being used for catheterization. Once the stylet/guidewire isplaced, the vascular catheter may be advanced so that the distal tip ofthe catheter is at a known position relative to the distal tip of thestylet/guidewire. The stylet/guidewire may then be removed.

FIGS. 9F through 9H show distances between the fluid exit port and thetemperature sensor(s) and distances between the catheter/stylet tip andthe sensor(s)/ports. FIG. 9F shows the axial distance aa between theinjectate exit or port, and the distal or singular temperature sensor.The axial distance bb is the distance between the fluid exit port andthe proximal temperature sensor. The axial distance cc is the distancebetween the distal temperature sensor and the proximal temperaturesensor. These distances may be positive or negative. Although 2temperature sensors are shown here, the device may have one sensor ormore than 2 sensors.

Distance aa may be about 0 mm. Alternatively, distance aa may be a rangeof about 0 mm to about 0.5 mm, or about 0 mm to about 1 mm.Alternatively, distance aa may be a range of about 0 mm to about 2 mm.Alternatively, distance aa may be a range of about 0 mm to about 3 mm.Alternatively, distance aa may about 3 mm to about 5 mm. Alternatively,distance aa may about 5 mm to about 10 mm. Alternatively, distance aamay be a range of about 0 mm to about 100 mm. These distances mayalternatively be negative. For example, distance aa may be about 1 mm ormay be about −1 mm. In the case of 1 mm, the distal temperature sensorwill be distal to the fluid exit port. In the case of −1 mm, the fluidexit port will be distal to the distal temperature sensor. This is truefor all dimensions provided in association with FIGS. 9F-9H.

Distance bb may be about 10 mm. Alternatively, distance bb may be arange of about 0 mm to about 10 mm. Alternatively, distance bb may be arange of about 8 mm to about 12 mm. Alternatively, distance bb may be arange of about 5 mm to about 15 mm. Alternatively, distance bb may be arange of about 1 mm to about 100 mm. Alternatively, distance bb mayabout 3 mm to about 5 mm. Alternatively, distance bb may about 5 mm toabout 10 mm. Alternatively, distance bb may be a range of about 0 mm toabout 100 mm. These ranges may also be negative distances.

Distance cc may be about 10 mm. Alternatively, distance cc may be arange of about 0.0 mm to about 5 mm Alternatively, distance cc may be arange of about 5 mm to about 15 mm. Alternatively, distance cc may be arange of about 15 mm to about 20 mm. Alternatively, distance cc may be arange of about 1 mm to about 100 mm.

Distance dd in FIG. 9G is the distance between the fluid exit port andeither the distal or proximal temperature sensor. The distance is shownwith respect to the proximal temperature sensor here, but distance ddmay apply to either. Alternatively, only one temperature sensor may bepresent. Distance dd may be about 0.75 mm. Alternatively, distance ddmay range from about 0.25 mm and 1.5 mm. Alternatively, distance dd mayrange from about 0.1 mm and 5 mm.

FIG. 9H shows the axial distance ee between the fluid exit port and theend of the catheter and/or stylet. Distance ee may be about 0 mm.Alternatively, distance ee may range from about 0 mm and about 1 mm.Alternatively, distance ee may range from about 0 mm and about 3 mm.Alternatively, distance ee may range from about 0 mm and about 5 mm.Alternatively, distance ee may range from about 5 mm and about 10 mm.Alternatively, distance ee may range from about 0 mm and about 100 mm.These distances may be positive or negative.

FIG. 9I shows an embodiment of the vascular catheter navigation devicewhich includes only one sensor and includes conduit 902 in the system.Various embodiments of the system including a conduit will be describedin more detail elsewhere herein. Conduit 902 incorporates the injectateexit port shown by an X. Distance ff shown here is the longitudinaldistance between the fluid injectate exit port of the conduit and thesensor.

FIG. 9J shows an embodiment similar to that in FIG. 9I where thedistance gg represents the radial distance between the fluid injectateexit port of the conduit and the sensor.

FIG. 10 shows an embodiment of the vascular catheter navigation devicewhich can be used with any catheter, or in other words, where thetemperature sensor(s), the injectate lumen, the controller, and lockingmechanism are included with the stylet/guidewire. FIG. 10 shows anembodiment with two thermocouples, distal thermocouple 1012 and proximalthermocouple 1010, and injectate exit port 1002 as part ofguidewire/stylet 1001. Alternatively, the stylet/guidewire may only haveone temperature sensor, or may have more than two temperature sensors.The stylet/guidewire may include features 1014 to help align thestylet/guidewire and the catheter. This embodiment may include a tipportion 1006, such as a molded urethane, nylon, silicone, or otherpolymer portion, for embedding the temperature sensor(s). Also shownhere is an optional guidewire/stylet coil 1008 and the distal tip ofcatheter 1018. In the cross sectional view, injection lumen 1016 canalso be seen.

This embodiment may include torque or locking device 1022 which may beused to lock the stylet to the proximal end of the catheter, for exampleusing luer lock 1020 at the proximal end of catheter 1018. Thetorque/locking device may be locked to the stylet/guidewire so that thestylet/guidewire won't move with respect to the vascular catheter.Controller (not shown) may include and/or control an infusion mechanismvia fluid port 1026 as well as read data from the temperature sensor(s)via temperature port 1004. The controller may be located near theproximal end of the stylet, or may be located several inches or feetfrom the proximal end of the stylet. Temperature sensor leads 1024 arealso shown. The infusion may be steady or intermittent or consist ofboluses.

FIGS. 11A-I show various views of various embodiments of astylet/guidewire version of the vascular catheter navigation device.

The stylets shown in 11A-11I and some other embodiments serve severalfunctions, including: 1) Stiffening of the catheter to aid in insertion2) providing a medium for fluid delivery and 3) providing a channel forthe wiring for the temperature sensor or sensors. FIG. 11A is a crosssection of the stylet such as that shown in the embodiment of FIG. 10.Two temperature sensors are shown here, but the device may include one,or more than two sensors.

FIG. 11B shows an embodiment of a stylet which includes three componentsin a triple lumen, heat shrink, and/or tubing housing 1102 whichcontains two temperature sensors 1104 and fluid lumen 1016.Alternatively, one or more than two temperature sensors may be present.

FIG. 11C shows an embodiment in which the stylet coil is made all, or inpart, out of the temperature sensor wires. FIG. 11D is a side view ofthe embodiment shown in FIG. 11C.

FIG. 11E shows an embodiment including an extrusion, or tube, (metal orplastic) which houses two temperature sensors as well as a fluid lumen.Alternatively, one or more than two temperature sensors may be present.

FIG. 11F shows an embodiment including an extrusion, or tube, (metal orplastic) which houses multiple thermocouples within one bundle as wellas a fluid lumen.

FIG. 11G shows an embodiment including a thin walled extrusion, or tube,where the temperature sensors are surrounded by the fluid lumen. One,two, or more than two temperature sensors may be present.

FIG. 11H shows an embodiment including an extrusion, or tube, (plasticor metal) which includes multiple temperature sensors, a fluid lumen, aswell as stiffener 1108 which may be a wire or a rod. One, two, or morethan two temperature sensors may be present.

FIG. 11I shows an embodiment including an extrusion, or tube, (plasticor metal) which includes a temperature sensor bundle as well as a fluidlumen. The temperature sensor bundle exterior may be made of similarmaterial to the outer extrusion which enables optional chemical or heatformed bond or weld 1106. One, two, or more than two temperature sensorsmay be present.

In some embodiments, it may be important to either fix, or preciselycontrol, the distance between the catheter tip and the guidewire/stylet,or be able to determine the distance between the catheter tip and theguidewire/stylet. It may also be important to able to fix the locationof the injection with respect to a temperature sensor or to know thedistance between the location of the injection exit port and atemperature sensor. The distance between the exit port and thetemperature sensors will have an effect on the temperature profileduring fluid infusion. These distances may be fixed across patients andscenarios, or may be different for different patient types and differentscenarios. For example, the distance may be different depending on thevasculature being accessed. The distance may be different for patientsof different weight, size, body mass index, health, age, sex, heartcondition, or other patient characteristics. The distance may bedifferent for different catheter sizes, catheters with different numbersand shapes of lumens etc.

In some embodiments, the stylet/guidewire is fixed, or locked, withrespect to the catheter tip using a torque device near the proximal endof the catheter as shown in FIG. 10.

In some embodiments, the user determines the relative alignment of thecatheter and stylet/guidewire by sight and then measures the relativedistance from two values.

FIGS. 12-17 show various embodiments of the vascular catheter navigationdevice which include various registration techniques to either fix, orknow, the distance between the temperature sensor or sensors on thestylet, and the catheter tip or fluid injection point.

FIG. 12 shows an embodiment with an indicator on the stylet/guidewirewhich is a fixed and known distance from a temperature sensor. In thisembodiment, the user aligns the tip of catheter 1202 with indicator, ormark 1204, on stylet 1206 before insertion into the patient. Therelative distance 1208 of the catheter tip to the tip of the stylet maybe locked, preferably at the proximal end, using a torque device, alocking rotating hemostasis valve, a tuohy-borst valve, or other lockingmechanism, before the catheter is inserted into the patient. Theindicator on the guidewire/stylet may be a visible mark, such as a redstripe or dot, or a tactile mark, such as a bump or groove, or othertype of indicator.

FIG. 13 shows an embodiment with raised area, or bump 1302, on thestylet which is a fixed and known distance from the distal temperaturesensor. This allows the user to align the tip of the catheter with thebump on the stylet, either visually, or by tactile feel. This alignmentmay be done outside the body or inside the body. In some embodiments,the bump is small or soft enough that the stylet may be removed from thecatheter after placement in the anatomy.

FIG. 14 shows an embodiment similar to that shown in FIG. 13 where atemperature sensor 1104 acts as the bump on the stylet.

FIG. 15 shows an embodiment where jig, or block, or aligner 1502, isused to align the tip of the catheter a fixed and known distance fromthe tip of the stylet. The relative location of the catheter withrespect to the stylet is then locked, at the proximal end, using atorque device, a locking rotating hemostasis valve, a tuohy-borst valve,or other locking mechanism, and/or at the distal end, using a securingstyle conduit (disclosed in detail elsewhere herein), or both. Jig orblock 1502 may itself be adjustable so that it can align the fluid exitport (here the distal end of the catheter) with the temperature sensorfor a variety of different lengths.

FIG. 16 shows an embodiment similar to that shown in FIG. 13 whereinflatable balloon 1602 is used as the bump to align the catheter andthe stylet. The balloon may be annular or on one or more sides of thestylet. The balloon may be inflated for use during alignment, and eitherleft inflated during placement, to lock the stylet in position withrespect to the catheter, or deflated during placement (where thecatheter and stylet have been locked to each other using a torque orvalve). In this embodiment, the stylet or catheter will include aninflation lumen to inflate and deflate the balloon. The balloon may bedeflated for removal of the stylet after placement of the catheter.

FIG. 17 shows an embodiment of the vascular catheter navigation devicewhich includes a sensor 1702 which can sense when it is inside thecatheter tip during use. For example the sensor may be magnetic,ultrasound, light, temperature, etc. In some embodiments, proximaltemperature sensor 1704 is used as a sensor to determine when theproximal temperature sensor is inside the catheter tip. The temperaturevs. time curve shape after injection of injectate will show a specificprofile when the temperature sensor is just inside the catheter tip, andcan be used to identify this alignment. This embodiment may include one,two, or more temperature sensors.

In some embodiments, controlling the flow patterns of the injectate exitmay be important. to achieve consistent results. It may also beimportant to contrast the flow of the injectate with that of the bloodflow within the vasculature/heart. The flow of the injectate may bepurposefully made either more laminar or more turbulent to achieve thesegoals. Some embodiments may include features that direct the flow andare a part of the catheter or stylet. These features may be surfacefeatures, like dimpling, or an orange peel finish, that change thesurface finish of the catheter or stylet. These features may be part ofthe OD of stylet/temp sensors or ID of fluid lumen or both.

FIGS. 18A and B show 2 possible embodiments for a flow director (tocreate laminar or turbulent flow) in injectate lumen 1016 of thevascular catheter navigation device. Flow director 1802 may be at theend of the injectate lumen, as shown in FIG. 18A, or it may be set backfrom the tip of the lumen exit, as shown in FIG. 18B.

FIGS. 19A-C show other embodiments of the vascular catheter navigationdevice where the shape of the injectate lumen controls the type of flowof the fluid exiting the lumen. Some of the parameters which may bevaried include injectate lumen opening area, shape, surface condition,etc. Temperature sensor and/or stiffener 1902 is also shown.

Some embodiments may vibrate the stylet and/or catheter to createturbulent flow of the injectate from the injectate lumen.

FIG. 20 shows an embodiment of a stylet without an injection lumen. Thefluid may be introduced through another catheter lumen (possibly on aseparate catheter) upstream from the catheter tip, closer to theinsertion site, or elsewhere. For example, fluid may be injected via“buddy” catheter 2002 shown here alongside the vascular catheter. Fluidmay also be heated or cooled via a heating/cooling element on thecatheter or on a “buddy” catheter. An infusion “buddy” guidewire/styletis also envisioned.

FIG. 21 shows features 2102 in the injectate lumen that enhance acontrolled turbulent flow.

FIG. 22 shows features 2202 in the injectate lumen that create acontrolled laminar (or less turbulent) flow.

Note that several embodiments disclosed herein show 2 sensors. In any ofthese embodiments, one, two, or more sensors may be used.

In some embodiments the outer diameter (OD) of the stylet is around 1 mmor less. In some embodiments the OD of the stylet is around 0.5 mm orless. In some embodiments the OD of the stylet is around 1.5 mm or less.In some embodiments the stylet could range in OD from about 0.2 mm toabout 5 mm.

In some embodiments, where the catheter is double or triple lumen, thestylet functionality may be broken into distinct parts (fluid,stiffener, temperature sensing) etc. and multiple stylets may be used inmultiple lumens of the catheter.

Many types of temperature sensors may be used in any of the embodimentsdisclosed herein, including thermocouples, fiber optic, resistive,bimetallic, thermometer, state-change, silicon diode, thermistors,optical temperature measurement (infrared or otherwise), mercurythermometers, manometers, etc.

In addition to infusing fluids, as disclosed elsewhere herein, othermethods to create a thermal change at or near the tip of thecatheter/stylet may be used. Fluids at a temperature higher than bodytemperature may be introduced, a resistive heating element, or a piezoelectric cooling element, etc. may be included in the catheter, on thecatheter, on the guidewire/stylet, or at the injector, outside of thebody. Alternatively, the injected fluid may be at a different, althoughnot strictly controlled, temperature than body temperature and thistemperature difference (between body temperature and injectatetemperature) is measured and tracked by the controller.

In embodiments with a resistive heating element, the resistive heatingelements may be on the catheter or on a stylet. In embodiments where itis on the catheter it may be on the outside of the catheter or on theinside of one or more lumens of the catheter. Alternatively, it may beon the guidewire/stylet. In embodiments where it is on theguidewire/stylet, it may be within the catheter lumen, partially withinthe catheter lumen, or external to the catheter lumen, where it isexposed to blood. When heating/cooling blood, injection of an injectatemay not be required.

As shown in FIGS. 23A-E and FIGS. 24A-E. A graphical user interface maybe displayed in the form of a small screen/display 2314, a large screen,a projection, in virtual reality or augmented reality goggles, etc. Themajor categorization of user interactions may have any combination ofuser alerts: 1) icon 2) color of icon or warning light 3) auditory tonethat accompanies the alert 4) visual map of the body which matches thelocation of the catheter tip and with the type of alert 5) writtenphrase or word on the display indicating the status or alert, vibration,etc. The categories may be the following: 1) ‘Continue Advancing’, whichmeans that that the catheter tip is advancing through a peripheral veinor has rounded the bend and is approaching the superior vena cava. Thismode will be accompanied by visual and auditory feedback indicating apositive state such as green lighting and iconography and a positivetone. 2) ‘Placement Correct’, with the checkmark iconography shows thatthe tip has arrived at the proper location—the cavo atrial junction forPICC lines, or perhaps another location for another type of catheterinsertion. Positive tone and lighting may also accompany this state. 3)If the catheter encounters an opposing flow, the warning, ‘Redirect’ mayappear. This is the warning if the catheter advances down an azygousbranch, advances into the IVC, or has been placed in an artery. Sincethis is not a positive state, lighting or iconography that is red,yellow or orange may accompany this state along with a tone whichdepicts that a non-favorable situation is in effect. A less pleasantfrequency, pitch and tone may accompany. 4) if the catheter is in theheart, either in the atrium or the ventricle, the user may be alertedwith the heart icon and/or “In Heart” warning. A negative color and tonemay accompany this state. 5) if the catheter tip is up against a wall ofa vein, or has an obstruction of some kind the

“Adjust” warning may display. A negative color and tone may accompanythis state. Also shown in FIGS. 23A-E and 24A-E is catheter 2302, stylet2304, temperature adapter 2306, fluid adapter 2308, prime button 2310,and insertion/tracking button 2312.

The graphical user interface (GUI) may display in real time the locationof the tip of the catheter relative to the 3D space through which it isnavigating. The graphical user interface shown in FIGS. 23A-E and 24A-Eare two dimensional, however some embodiments include 3D displays whichmay also communicate the information in three dimensions.

Note that although some embodiments disclosed herein incorporate thesensor(s) into the vascular catheter, the vascular catheter navigationdevice may be a stand-alone device which fits inside a vascularcatheter, and can be removed once vascular catheter placement has beencompleted. The vascular catheter navigation device, for example, mayserve as a stylet or guidewire for a standard vascular catheter.

FIGS. 25A-C show embodiments of the vascular catheter navigation devicewhich include a conduit to control fluid flow exiting from the fluidexit point of the device. In this embodiment, conduit 2502 is attachedto guidewire/stylet 2504, forming a stylus/conduit combination device.Conduit 2502 is designed to fit inside the ID of infusion lumen 2506 ofvascular catheter 2508. In this figure, vascular catheter 2508 onlyincludes one lumen, the infusion lumen, however multiple lumens, inaddition to the infusion lumen, may exist in the vascular catheter.

In some embodiments, guidewire/stylet 2504 includes core 2510, coil2512, endcap 2514 and temperature sensor 2516. Core 2510 may include astiffening wire, which may be tapered, and leads for the temperaturesensor. The temperature sensor may be incorporated into the endcap, orit may be separate. One or more temperature sensor(s) may be present.The temperature sensor may be a thermocouple. A larger cross sectionaldimension of the thermocouple may dampen temperature measurements wherea smaller cross sectional dimension of the thermocouple may allow forquicker response times. The diameter or cross sectional dimension 2526of a thermocouple may be about 0.2 mm-0.3 mm. Alternatively, thediameter or cross sectional dimension 2526 of a thermocouple may beabout 0.02 mm to about 0.5 mm.

In some embodiments, conduit 2502 has length 2520 and includes fluidflow passage or passages 2518 with diameter or cross sectional dimension2522. The flow passages may be circular in cross-sectional shape, oroval, or of any shape. A flow passage may be approximately 0.4-0.6 mm indiameter or cross sectional dimension. Alternatively a flow passage maybe approximately 0.1-1.0 mm in diameter or cross sectional dimension.Alternatively a flow passage may be approximately 0.01-2.0 mm indiameter or cross sectional dimension. Conduit length 2520 may be about4-8 mm. Alternatively, conduit length 2520 may be about 0.5 mm-20 mm.

The cross sectional area and shape of the flow passages will determineflow velocity exiting the conduit. The number of flow passages will alsoaffect the flow parameters of the fluid exiting the conduit. Preferably,the fluid infusion rate may be about 2-3 ml/min. Alternatively, thefluid infusion rate may be about 3-5 ml/min. Alternatively, the fluidinfusion rate may be about 5-10 ml/min. Alternatively, the fluidinfusion rate may be about 1-5 ml/min. Conduit exit flow velocity ispreferably about 60-100 cm/sec. Alternatively, conduit exit flowvelocity is about 1-300 cm/sec.

Conduit 2502 may serve several purposes:

1) Essentially sealing the distal end of the infusion lumen of thevascular catheter while allowing fluid flow through/past the conduit sothat when fluid is infused through the infusion lumen of the catheter,the majority of the fluid exits the vascular catheter via flowpassage(s) 2518. It is important to note that the conduit doesn't fullyocclude the infusion lumen of the catheter, it allows fluid to passthrough it and in some cases, through channels around it.

2) Allowing the distance 2524 between the fluid exit point 2503 and thesensor on the guidewire/stylet to be known and fixed for more controlledtemperature measurements in the vasculature. The fluid exit point may bethe exit point of the distal end of the flow passage(s) of the conduit,or may be the distal end of the catheter, depending on whether theconduit is partially sticking out of the distal end of the catheter.Distance 2524 may be about 0.0 to 1.0 mm. Alternatively, distance 2524may be about 0.5 to 1.0 mm. Alternatively, distance 2524 may be about0.0 to 2.0 mm. Alternatively, distance 2524 may be about 0.0 to 5.0 mm.Alternatively, distance 2524 may be about 0.0 to 10.0 mm. “about 0.0” or“Essentially zero” herein may mean plus or minus 1 mm, or “Essentiallyzero” may mean plus or minus 2 mm, or “Essentially zero” may mean plusor minus 3 mm. This may be the case with any of the embodimentsdisclosed herein.

3) Centering or otherwise aligning the fluid exit point(s) of theconduit with the temperature sensor(s).

4) centering or otherwise aligning the fluid exit point(s) with thecatheter tip

5) Controlling the flow characteristics of the fluid exiting the exitpoint(s). For example, the size, shape and number of exit ports willcontrol the flow characteristics of the fluid exiting the port(s).Parameters such as turbulence, flow velocity, volumetric flow rate, flowvolume, etc. may be controlled. The cross-section of the flow passages2518, in addition to the fluid infusion rate, will determine thevelocity of the infusion rate exiting the flow passages 2518. Thevelocity of the infusion rate may be adapted to the velocity of theblood flow.

Allowing the outer surface of the conduit to essentially seal with theinner surface of the infusion lumen of the vascular catheter withouthaving to perfectly align the guidewire/stylet with the vascularcatheter. Because the vascular catheter is larger, and more flexible,than the stylet, the relative alignment of the distal tips of each mayvary during a procedure. Where the length of the conduit is longer thanthis variance, the conduit can still seal the infusion lumen of thevascular catheter even if the distal tips of the stylet/conduit comboand the vascular catheter move with respect to each other. Alternativelyor additionally, the conduit may fix the guidewire/stylet to thevascular catheter so that one does not move substantially relative tothe other at least longitudinally.

The cross sectional dimension/diameter of the conduit may be about0.5-1.5 mm. Alternatively, the cross sectional dimension/diameter of theconduit may be about 0.1-3 mm. The clearance between the outside of theconduit and the inside of the infusion lumen of the vascular catheter insome embodiments will be small enough to allow an essential seal betweenthe outside of the conduit and the inside of the infusion lumen of thevascular catheter. This encourages essentially all the infused fluid toexit flow passages 2518 which controls the distance between the fluidexit and the temperature sensor. The clearance between the outside ofthe conduit and the inside of the infusion lumen of the vascularcatheter may also be great enough to allow the stylet/conduitcombination to move within the infusion lumen of the vascular catheter,for positioning, and/or for removal. The outer surface of the conduitmay be coated or manufactured from a lubricious material, such as PTFE,a hydrophobic material, a hydrophilic material, etc. The clearancebetween the outside of the conduit and the inside of the infusion lumenof the vascular catheter may be about 0.070-0.080 mm. Alternatively, theclearance between the outside of the conduit and the inside of theinfusion lumen of the vascular catheter may be about 0.05-0.1 mm.Alternatively, the clearance between the outside of the conduit and theinside of the infusion lumen of the vascular catheter may be about0.001-1.00 mm.

Note that the clearance between the outside of the conduit and theinside of the infusion lumen of the vascular catheter may be differentfor embodiments of the conduit which expand/contract, or have featureswhich expand/contract, such as those shown in FIGS. 27, 28, 29A-C, 30,36A-C. For example, the clearance in the contracted state may be greaterthan that of a conduit which does not expand/contract and the clearancein the expanded state may be less than that of a conduit which does notexpand/contract. For example, the clearance in the expanded state may beessentially zero.

FIG. 25A shows the distal end of conduit 2502 essentially aligned withthe distal end of catheter 2508. (Note that “distal” herein means theend of the vascular catheter navigation device which enters the body.“Proximal” herein means the end of the vascular catheter navigationdevice which does not enter the body.) FIG. 25B shows an embodimentwhere the distal end of the conduit is designed to sit inside the distalend of the infusion lumen of the catheter for infusion. FIG. 25C showsan embodiment where the distal end of the conduit is designed to sitoutside the distal end of the distal end of the infusion lumen of thecatheter for infusion. Note that some embodiments may be designed to sitin more than one position.

The fluid exit point 2503 is shown for the devices in FIGS. 25A-25C andin other figures. Note that the exit point may be the distal end of theconduit, or the distal end of the catheter, depending on the alignmentof the conduit with the distal end of the catheter.

In use, the stylet/conduit combination device is inserted (or comesinserted) into the infusion lumen of the vascular catheter. The catheteris then inserted into, advanced through, the vasculature. As the deviceis advanced, fluid is infused through the infusion lumen. Because theconduit essentially seals the infusion lumen of the catheter, the fluidexits the system through the flow passages of the conduit, and the fluidflows through the vasculature and the temperature of the blood/fluid inthe vasculature is sensed by the temperature sensor. The distancebetween the exit point(s) of the fluid and the temperature sensor isfixed/known and the temperature vs. time curve is related to the flowcharacteristics within the vessel. The different signatures of thesecurves are used to identify the location of the tip of the vascularcatheter navigation device. After the system has been navigated to itsdesired location, the stylet/conduit combination device is removed, andthe infusion lumen of the vascular catheter serves as a standardinfusion lumen. The stylet/conduit combination device may be reinsertedinto the infusion lumen of the vascular catheter later on to confirm thelocation of the tip of the vascular catheter.

FIG. 26 shows an embodiment of the vascular catheter navigation devicewhere the flow passage is within the guidewire/stylet component itself.In this embodiment, the conduit serves to essentially seal the end ofthe infusion lumen of the catheter, but the flow passage flows betweenstylet core 2510 and stylet coil 2512 and exits via openings 2602between the coils.

FIG. 27 shows a variation of the conduit which includes proximal flange2702. The flange may serve as a seal, essentially sealing the conduit tothe ID of the infusion lumen of the catheter, when fluid injectedthrough the infusion lumen of the catheter above a certain pressure.When fluid is no longer infused through the infusion lumen, or when theinfusion pressure is reduced below a certain pressure, flange 2702 maycollapse slightly, reducing the diameter or cross sectional area of theconduit at the flange, which allows the stylet/conduit combinationdevice to be removed from the vascular catheter after location of thevascular catheter has been established. Alternately, the flange mayinvaginate and flip direction during withdrawal movement, easing removalof the stylet/conduit combination device. FIG. 28 shows a variation ofthe embodiment shown in FIG. 27 where the conduit has both a proximalflange and a distal flange. Note that, in these, as well as otherembodiments disclosed herein, during use, i.e., during catheternavigation, the distal end of the conduit may be flush with the distaltip of the catheter, distal to the distal end of the catheter, orproximal to the distal end of the catheter.

FIGS. 29A-C show an embodiment of the vascular catheter navigationdevice where the conduit includes a thin-walled inflatable structure.FIG. 29A shows a conduit with thin-walled, inflatable proximal portion2902 and distal portion 2904, where distal portion is bonded, orotherwise attached, to the stylet. Proximal portion 2902 of the conduitincludes opening(s) 2906. Proximal conduit portion 2902 expands whenfluid in infused through the infusion lumen of the catheter, essentiallysealing the inflatable portion up against the inner walls of theinfusion lumen. The infusion fluid also exits the catheter via openings2906. The openings must be small enough to allow the pressure withinportion 2902 to increase so that this portion “inflates” inside theinfusion lumen. The openings must be large enough to allow adequatefluid to escape into the blood stream to make meaningful temperaturemeasurements. The diameter or cross-sectional dimension of theopening(s) may be about 0.4-0.06 mm. Alternatively, the diameter orcross-sectional dimension of the opening(s) may be about 0.05-1.0 mm.The length 2910 of proximal section 2902 of the conduit may be about0.3-0.5 mm. Alternatively, the length 2910 of proximal section 2902 ofthe conduit may be about 0.3-20 mm.

To remove the stylet/conduit component from the vascular catheter, thefluid infusion is reduced, or reversed, to “deflate” proximal section2902 of the conduit so that the stylet/conduit can be removed. This isshown in FIG. 29B. In some embodiments, deflation may not be necessaryand the stylet/conduit may be removed from the vascular catheter whilefluid infusion is taking place.

FIG. 29C shows a variation of the inflatable conduit with collar 2912which may help direct fluid flow as it exits the conduit.

One of the advantages of an “inflatable” conduit is that the shape ofthe conduit can conform to any shaped infusion lumen, whether round,semi-circle, triangular, oval, etc. The difference in cross sectionalarea between the deployed vs. un-deployed conduit can be fairly great,which is useful in smaller infusion lumen devices.

FIG. 30 shows an embodiment of the conduit which has thin-walled “skirt”3002. This “skirt” expands and contracts similar to the “inflatable”portion of the embodiment shown in FIGS. 29A and B.

FIG. 31 shows an embodiment of the conduit which includes feature(s)3102 to help direct the fluid flow exiting the conduit. The feature maydirect flow in a parallel manner, as shown in FIG. 31, inward, as shownin FIG. 32, or outwardly, as shown in FIG. 33, or in any other manner.

FIG. 34 shows an embodiment with deflector 3402 which helps keep thesystem away from the wall of the blood vessel. The deflector may be asphere, or essentially spherical in shape or any other shape. Thediameter or cross section dimension of the deflector may be about0.3-0.4 mm. Alternatively, the diameter or cross sectional dimension ofthe deflector may be about 0.01-1.0 mm.

FIG. 35 shows an embodiment of the conduit which is conical shaped tohelp seal within the infusion lumen of the catheter during injection.

FIGS. 36A-C show an embodiment of the vascular catheter navigationdevice which includes a compressible conduit 3606. The compressibleconduit may be made out of silicone, polymer, or other suitablematerial. FIG. 36A shows the conduit in its compressed state. In thisstate, the conduit essentially seals the infusion lumen of the catheter.FIG. 36B shows the compressible conduit in its uncompressed state, whichreduces the diameter/cross-sectional dimension so that it may berepositioned and/or removed. The compressing/uncompressing of theconduit may be performed by rod or hypotube or tube 3602 which isconnected to the proximal end of the compressible conduit and can bemanipulated (pushed, pulled, twisted etc.) from the proximal end of thecatheter to compress and uncompress the conduit. FIG. 36C shows avariation of the system which allows the user to compress/uncompress theconduit by rotating rod/hypotube/tube 3604 which has threads whichengage with the conduit. (New embodiment idea: A very small ballooncould be used to initiate and remove the seal. This is more applicablefor very large catheters.)

FIGS. 37A-F show 2 different cross-sectional views of variousembodiments of the vascular catheter navigation device. FIG. 37A showsan embodiment where guidewire/stylet 2504 is generally centered inconduit 2502 within infusion lumen of vascular catheter 2508. Flowpassage(s) 2518 may have different cross sectional shapes, for example,spherical, triangular, those shown here and others. One, two, or moreflow passages may be present. The guidewire/stylet may include sensorlead wires 3702.

FIG. 37B shows an embodiment of the vascular catheter navigation devicewhere the guidewire/stylet is off center. The cross sectional views showvarious possible configurations of the guidewire/stylet and fluidpassages. The flow passage(s) may be circular, crescent shaped etc. one,two or more flow passages may be present in any of the embodimentsdisclosed herein. Note that the conduit may be a simple tube, as shownby 3704.

FIG. 37C shows an embodiment of the vascular catheter navigation devicewhere the guidewire/stylet is off center and the tip of theguidewire/stylet is angled to align with flow passage in the conduit sothat temperature sensor 2516 is approximately aligned with a flowpassage. The tip of the guidewire/stylet may be aligned in other ways aswell, for example, to fall between flow passages or to simple be nearthe center of the catheter. The cross sectional views show variouspossible configurations of the guidewire/stylet and fluid passages. Theflow passage(s) may be circular, crescent shaped etc. The conduit may bea simple tube.

FIG. 37D shows an embodiment of the vascular catheter navigation devicewhere the conduit is a simple tube, and the guidewire/stylet is eitherfloating in the ID of the conduit (here the ID of the conduit is thesame as the flow passage of the conduit), or attached to the inner wallof the conduit. The guidewire/stylet may be angled so that thetemperature sensor is more aligned with the center of the conduit flowpassage, or straight, or bent or curved in some other way.

FIG. 37E 37D shows an embodiment of the vascular catheter navigationdevice which includes cage or scaffold 3706 which centers sensor 2516over a central flow passage within the conduit. The cage/scaffold may bemade from metal wire, polymer, may be made from a porous material, etc.Cage/scaffold may be embedded in, or attached to, the conduit.

FIG. 37F shows an embodiment of the vascular catheter navigation devicewhere conduit 2502 does not have an outer surface. In this embodiment,flow passages are in direct contact with the ID of catheter 2508.

FIGS. 38A-E show some possible architectures of various embodiments ofthe vascular catheter navigation device. FIG. 38A shows vascularcatheter 2508, guidewire/stylet 2504 and conduit 2502, along with IV bag3802, with optional infusion pump 3804, where the infusion bag isconnected to the fluid infusion port 2806 of the vascular catheter. Theguidewire/stylet is inserted/removed to/from the catheter via styletport 3808. In some embodiments, the stylet port of the catheter may bethe same port as the infusion port. Stylet/sensing connector 3810connects to controller 3812, which may include display 3814, as well asone or more controls 3816. In this embodiment the infusion of fluidthrough the vascular catheter and through the flow passage(s) of theconduit is controlled by the IV bag/infusion pump. The IV bag may be setto a consistent drip, flow, and/or may be controlled by the infusionpump. In this embodiment, the IV bag and/or infusion pump, is connectedto the vascular catheter without going through the controller. FIG. 38Bshows a similar embodiment, except that the flow of IV fluid from the IVbag is controlled by the controller. IV bag 3802 is connected to thecontroller via IV fluid line 3818. The controller controls the infusionof fluid from the IV bag and delivers the fluid to the catheter viacatheter fluid line 3820. The controller could be disposable orre-usable. The kit could also come with disposable lines which attach tothe IV bag or hospital's infusion pump.

FIG. 38C shows an embodiment of the vascular catheter navigation devicewhich includes fluid pump 3822, such as a syringe pump. The fluid pumpmay be a standard off the shelf fluid pump. Note that in thisembodiment, the fluid pump does not connect to the controller.

FIG. 38D shows an embodiment where fluid pump 3824 connects to thecontroller, so that the controller can control the fluid delivery to thecatheter via the fluid pump. The controller may have a module thatallows the user to attach an off the shelf fluid pump, or the controllermay require a specific fluid pump. The fluid pump and/or the syringecartridge within the fluid pump may be disposable.

FIG. 38E shows an embodiment where the fluid pump is incorporated intocontroller 3812. The fluid pump and/or the syringe cartridge within thefluid pump may be disposable.

FIG. 39A is a longitudinal cross sectional view of the vascular catheternavigation device including conduit 2502, guidewire/stylet 2504, sensor2516 and vascular catheter 2508.

FIG. 39B shows an embodiment of the vascular catheter navigation devicewith multiple conduits along the length of the guidewire/stylet. Theremay be 0, 1, 2, 3, 4, 5, 6 or more conduits.

FIG. 39C shows an embodiment of the vascular catheter navigation devicewith conduit 2502, as well as securing style conduits 3902. In someembodiments, these securing style conduits are inflatable, such asballoons, but they may also be compressible, such as silicone or anothersoft/compliant material, such as any suitable polymer. The securingstyle conduit may alternatively be made from a harder material, such asepoxy, or metal, or polymer etc. Preferably, the securing style conduitssecure the guidewire/stylet to the inner lumen of the catheter so thatthe stylet does not move significantly longitudinally with respect tothe catheter. As a result, the distance between the fluid exit point,and the sensor, is essentially fixed. Movement of the sensor withrespect to the fluid exit point may be limited to plus or minus 1 mm. OrMovement of the sensor with respect to the fluid exit point may belimited to plus or minus 2 mm. Or Movement of the sensor with respect tothe fluid exit point may be limited to plus or minus 3 mm. Preferably, asecuring style conduit also allows fluid to flow past it as it issecuring, and through the catheter lumen during infusion. There may bezero, 1, 2, 3, 4, 5, 6 or more securing style conduits. In embodimentswhere the guidewire/stylet includes a balloon, it will also include aninflation lumen. Balloons may be relatively non-compliant or relativelycompliant. The advantage of a non-compliant balloon is that it willretain its shape, or roundness, when inflated beyond a criticalpressure. This will prevent the balloon from conforming to the infusionlumen thus filling it. Instead, a non-compliant balloon will remainrelatively circular when inflated, and fluid flow lumens will beavailable between the inner wall of the catheter infusion lumen, thestiffener/electrodes, and the securing style conduit, as shown in FIG.39G.

FIG. 39D shows an embodiment of the vascular catheter navigation devicewith securing style conduit 3902. In this embodiment, the securing styleconduit may serve as the conduit. The securing style conduit may be atthe tip of the catheter or it may be further back proximally from thetip of the catheter, by length 3904. Length 3904 may be about 0-0.5 mm.Alternatively, length 3904 may be about 0-1.0 mm. Alternatively, length3904 may be about 0.5-1.0 mm. Alternatively, length 3904 may be about0-5 mm. Alternatively, length 3904 may be about 0-10 mm. Alternatively,length 3904 may be about 0-20 mm. Alternatively, length 3904 may beabout 0-30 mm. Alternatively, length 3904 may be about 0-40 mm.Alternatively, length 3904 may be about 0-50 mm. Alternatively, length3904 may be about 0-60 mm. Alternatively, length 3904 may be about 0-70mm. Alternatively, length 3904 may be about 0-80 mm. Alternatively,length 3904 may be about 0-90 mm. Alternatively, length 3904 may beabout 0-100 mm.

Length 3905 is the length between the sensor and the tip of thecatheter, which in this embodiment, is the fluid exit point. Thesecuring style conduit secures the guidewire/stylet to the infusionlumen of the catheter essentially fixing length 3905 during placement.Length 3905 may be about 0-0.5 mm. Alternatively, length 3905 may beabout 0-1.0 mm. Alternatively, length 3905 may be about 0.5-1.0 mm.Alternatively, length 3905 may be about 0-5 mm. Alternatively, length3905 may be about 0-10 mm. Alternatively, length 3905 may be about 0-20mm. Alternatively, length 3905 may be about 0-30 mm. Alternatively,length 3905 may be about 0-40 mm. Alternatively, length 3905 may beabout 0-50 mm. Alternatively, length 3905 may be about 0-60 mm.Alternatively, length 3905 may be about 0-70 mm. Alternatively, length3905 may be about 0-80 mm. Alternatively, length 3905 may be about 0-90mm. Alternatively, length 3905 may be about 0-100 mm.

The length of securing style conduit 3902 may be around 1 mm.Alternatively, the length of securing style conduit 3902 may be around1-2 mm. Alternatively, the length of securing style conduit 3902 may bearound 1-3 mm. Alternatively, the length of securing style conduit 3902may be around 1-4 mm. Alternatively, the length of securing styleconduit 3902 may be around 0.5-5 mm.

FIGS. 39E-39G show radial cross section views which reveal some of theembodiments of securing style conduit 3902. In FIG. 39E there are 3balloons, or soft protrusions around guidewire/stylet 2504. FIG. 39Fshows 2 balloons/protrusions and FIG. 39G shows only oneballoon/protrusion. Note that the flow passage(s) 3906 of these securingstyle conduits is the space(s) between the securing style conduit andthe inner lumen of catheter 2508, and similar to the conduit shown inFIG. 37F, does not have an outer surface. In several of theseembodiments, flow passages are in direct contact with the ID of catheter2508.

In one embodiment, securing style conduit 3902 is a small siliconeprotrusion or inflatable balloon near the distal end of thestylet/guidewire and as such, serves as the conduit. Before insertion,the guidewire/stylet is placed into the desired position so that thetemperature sensor is correctly positioned with respect to the distaltip of the catheter. At this point, the securing style conduit may be“activated”, for example, by inflating the balloon. The securing styleconduit holds the relative position of the guidewire/stylet and thecatheter during the placement process. During the placement process,fluid is injected through the catheter, past the securing style conduitand out the distal tip of the catheter. For removal, the securing styleconduit is either deflated, or is flexible enough to then allow theguidewire/stylet to be removed from the catheter. Sealing style conduit3902, when activated may be at a cross sectional dimension which isgreater than that of guidewire/stylet 2504. The cross sectionaldimension of the conduit may be about 0.05 mm greater than that of theguidewire/stylet. Alternatively, the cross sectional dimension of theconduit may be about 0.05-0.1 mm greater than that of theguidewire/stylet. Alternatively, the cross sectional dimension of theconduit may be about 0.05-0.5 mm greater than that of theguidewire/stylet. Alternatively, the cross sectional dimension of theconduit may be about 0.5-1.0 mm greater than that of theguidewire/stylet. Alternatively, the cross sectional dimension of theconduit may be about 1.0-2.0 mm greater than that of theguidewire/stylet.

FIG. 39H shows an embodiment of the vascular catheter navigation devicewhich includes multiple securing style conduits 3902. Multiple securingstyle conduits may allow for better longitudinal fixation between theguidewire/stylet and the catheter near the distal end of each. Note inthis example, length 3905 is essentially zero, which is the case whensensor 2516 is essentially at the distal tip of the catheter.“Essentially zero” may mean plus or minus 1 mm, or “Essentially zero”may mean plus or minus 2 mm, or “Essentially zero” may mean plus orminus 3 mm. This may be the case with any of the embodiments disclosedherein.

FIG. 39I shows an embodiment of the vascular catheter navigation devicewhere securing style conduit is a helix. The helix stabilizes andcenters the guidewire/stylet within the infusion lumen of the catheter,while allowing fluid to flow past the conduit. The helix is preferablyopen on the ends to allow fluid to flow therethrough.

FIG. 39J shows an embodiment of the vascular catheter navigation devicewhere securing style conduit 3902 is one or more metal wires orfilaments, which secure the stylet with respect to the catheter lumenvia outward mechanical force. The filaments may run the length of theguidewire/stylet and may be expanded/retracted using a mechanism at theproximal end of the guidewire/stylet. The filaments may be singlestrands of metal, or may be a cage, or spiral etc.

Markings or any other mechanism may be used to align the conduit withthe distal end of the catheter for catheter navigation. For example, amoveable marker may exist on the proximal end of the guidewire/stylet sothat the distal tip of the vascular catheter (possibly after having beencut to length) can be aligned with the conduit outside of the body, themoveable marker moved so that it lines up with the proximal end of thevascular catheter, and then the catheter may be inserted into the body.Other mechanisms include valves, such as a tuohy-borst valve, or clamps,torque device, etc. The length of the conduit may be long enough so thatexact alignment of the distal tips of the catheter and the conduit isnot necessary. For example, the vascular catheter may move about 0-2 mmwith respect to the guidewire/stylet during the placement procedure.Alternatively, the vascular catheter may move about 0-4 mm with respectto the guidewire/stylet during the placement procedure. The conduit maybe longer than this, for example, about 2-12 mm, to accommodate forthese changes in alignment and ensure that the conduit spans the distaltip of the catheter.

Some embodiments of the vascular catheter navigation device may restrictthe conduit from exiting the distal end of the vascular catheter. Someembodiments may allow the conduit to exit the distal end of the vascularcatheter. The proximal end of the conduit may be tapered to a smallercross sectional area proximally so that the conduit can be pulled backinto the catheter without catching.

FIGS. 40A-C show some different configurations of vascular catheterlumens and variations of embodiments of the vascular catheter navigationdevice which work with them. Vascular catheters may have one, two,three, four, five or more lumens. FIG. 40A shows some exampleconfigurations of 2 lumen vascular catheters. These configurationsinclude infusion lumen 2506 and auxiliary lumen 4002. The auxiliarylumen may be an additional infusion lumen, a sampling lumen, a pressurelumen, a guidewire/stylet lumen, a tools lumen, or a lumen used for anyother purpose. Shown here are guidewire/stylet 2504, conduit 2502, flowpassage(s) 2518 and vascular catheter 2508. Some of the variouscomponents of the vascular catheter navigation device, including thestylet, conduit, and flow passage(s) may have different cross sectionalshapes to accommodate the different shape vascular catheter lumens. Someexamples are shown here, but others are envisioned. The shape of theconduit may be preformed, for example in the form of a polymer conduit,or may take on the shape of the lumen, for example via an inflatable orconformable conduit, for example as shown in FIGS. 27, 28, 29A-C, 30,and 36A-C.

FIG. 40B shows some examples of configurations of 3 lumen vascularcatheters. FIG. 40C shows an example of a configuration of a 4 lumenvascular catheter.

Note that although embodiments disclosed herein show the vascularcatheter navigation device in an infusion lumen of a vascular catheter,it is also possible that the vascular catheter navigation device may beused in any lumen of a vascular catheter, for example a sampling lumen.It is also possible that more than one vascular catheter navigationdevices may be used at once in more than one lumen.

FIGS. 41A-F show various embodiments of a guidewire/stylet component ofthe vascular catheter navigation device. FIG. 41A shows guidewire/stylet2504, including core 2510, coil 2512, endcap 2514 and temperature sensor2516. Also shown here are temperature sensor lead wires 4102,temperature sensor lead wire insulation layer 4104, stiffener 4108 andcore enclosure 4106. The temperature sensor lead wires connect thetemperature sensor on the distal end of the device to the controller onthe proximal end of the device. There may be one, two or more leadwires. For example, a thermocouple will usually have 2 lead wires. Somethermocouples, however, may have 3 lead wires if one of the lead wiresis a ground wire. The lead wires are preferably made out of metal. Thelead wires may be insulated with insulation layer 4104 which surroundseach lead wire. In some embodiments, only one of the lead wires isinsulated. The insulation material may be made out of polymer such aspolyethylene or PTFE or polyimide or other suitable material and may ormay not be heat shrinkable. The stiffener may be made out of metal andmay be tapered to a smaller cross sectional dimension at the distal tip,or the stiffener may have a consistent cross section over its length.The stiffener may be round in cross sectional area or may be any othershape. The stiffener may alternatively be a polymer. The lead wire(s)may serve as the stiffener in which case, and additional stiffener willnot be present.

The core, which includes the lead wire(s) and an additional stiffener,if present, may be encapsulated with enclosure 4106. Enclosure 4106 maybe a tube made out of polymer, such as polyimide, polyethylene, PTFEetc., or metal or other suitable material. The enclosure mayalternatively be a dip or spray coating. The enclosure may be a heatshrinkable tubing.

FIG. 41A shows a guidewire/stylet where lead wires travel to the distalend of the stylet where temperature sensor 2516 exists separately fromendcap 2514 and proximally to the endcap. FIG. 41B shows an embodimentwhere the endcap and the temperature sensor are combined. FIG. 41C showsan embodiment where the temperature sensor is distal to the endcap.

FIG. 41D shows an embodiment of the stylet/guidewire where the coilserves as the lead wire(s). In this embodiment, the lead wire(s) exitthe core and are incorporated into the coil proximal to the temperaturesensor.

FIG. 41E shows an embodiment where lead(s) 4102 are made out ofconductive ink. In this embodiment, the lead(s) may be on the outside ofenclosure 4106. The ink may be deposited onto the enclosure. Theconductive ink lead(s) may be sandwiched between two enclosures. Notethat conductive ink may be used for any of the sensors, includingthermocouples, ECG, temperature sensors, etc., and may be printed on thestylet and/or catheter and/or conduit.

FIG. 41F shows an embodiment of the stylet/guidewire where the coilexists over the entire length, or substantially the entire length, ofthe stylet/guidewire.

FIG. 42A shows an embodiment of the stylet/guidewire where lead(s) 4102also serve as stiffener(s). The lead(s) may be encapsulated in enclosure4106 and connect to sensor 2516. Additional stiffness may be added tothis embodiment by using thicker leads, thicker/stiffer enclosure, forexample, metal braid or coil or filament reinforced polyimide or polymertubing etc. Alternatively, the gap between the enclosure and the leadsmay be filled with epoxy or adhesive. The leads may be welded or bondedto each other or to the enclosure. The enclosure may be co-extruded withone or more of the insulation layers of the lead(s), as shown in FIG.42B. Thermoset polymers and/or metals may be used in the enclosure,insulation and/or leads. Each lead may include an insulation layer oronly one lead may have an insulation layer or neither lead may includean insulation layer, for example in the embodiments where adhesive orepoxy is used to stiffen the stylet. In such embodiment, the leaddiameter, cross-section design, and material may be designed to matchdesired stiffness of the stiffener. One or more of the leads may bespiral, coiled, or braided to achieve desired stiffener mechanicalproperties.

FIG. 42C shows the embodiment shown in FIG. 42A with the addition of acoil.

Any of the guidewires/styli disclosed herein may be used with any of theembodiments disclosed herein including any of the conduit embodiments.

Some embodiments disclosed herein may be used to determine fluid levels,or hydration level, of a patient. Fluid levels are particularlyimportant when a patient has congestive heart challenges. A lower fluidlevel may result in lower amplitude pulses in the blood flow, where ahigher fluid level may result in greater amplitude blood flow pulses.Other flow patterns may be different between a hydrated patient and aless hydrated patient. These flow patterns can be detected usingembodiments disclosed herein. Hydration level can be monitored in apatient over time or compared among patients.

Where “sensor” or “temperature sensor” is used herein, other types ofsensors may be used, including any measurable parameter includingtemperature, opacity, light reflectivity, sound reflectivity, density,viscosity, ability to absorb light, ability to absorb sound, pressureetc.

FIG. 43 shows that an optical signal can provide information ondirection of blood flow and other blood flow parameters. In thisembodiment, the medium is light and the parameter measured is lightintensity and/or reflected light. Curve 4302 represents a measurement ofreflected light over time in a blood vessel where blood flow is towardthe device.

FIG. 44 shows an embodiment of a device which uses optical sensors.Fiber optic cables 4402 and 4404 can be used for transmission anddetection of light. One cable may be used to introduce the medium(light) and the other cable serves as a sensor for a parameter of themedium (light intensity/wavelength). A detector and emitter combinationcan be used or an optical detector can be used without an emitter,requiring only one fiber. In some embodiments, light at particularwavelengths may be used. For example, red light of approximately 620 nmto 750 nm may be emitted, which is reflected more by red blood cellsthan by saline, or saline diluted blood. Thus a response can indicate aflow direction or characteristic. This same embodiment can be enabledmore broadly with other types of visible light of about 350 nm-800 nmand near infrared light between about 400 and 1400 nm. This embodimentcan be achieved with detector and/or emitters that are located at thepoint of measurement and potentially used in combination with a flexcircuit. The optical measuring embodiment can also be used with the useof fiber optics (plastic, glass or other,) or light pipes where theactual detector and emitter are located in the controller and the lightpipe or fiber optic communicates information collected at or near thecatheter tip with the controller located outside the patient. This canbe performed with fiber optic lines which are about 0.1 mm to about 0.5mm in diameter or about 0.5 mm to about 4 mm in diameter. The fiberoptic cable(s) may have an insulated coating. In some embodiments, asingle optical fiber may be used to measure temperature.

FIGS. 45 and 46 show a triple lumen device and a double lumen devicerespectively, with 2 fiber optic cables.

FIG. 47 shows an embodiment which uses sonar and/or sound waves todetect blood direction. In this embodiment, the medium introduced issound and the parameter measured by sensors is reflected sound intensityand/or wavelengths. Sound is introduced via the device resulting insound waves 4702 transmitted into the blood vessel. Some sound waveswill be reflected back as reflected sound waves 4704 and can be measuredby a sensor, such as a microphone, on the device.

FIGS. 48 and 49 show an embodiment which uses one or more pressuresensors, with the aid of a turbulence inducer, to determinedirectionality of flow. A single pressure sensor 4804 or multiplepressure sensors can be used to detect the direction of flow withrespect to the catheter or pressure sensor. This embodiment can includemechanism 4802 that induce turbulent flow 4808 to create differentpressures at the reading location depending on if the flow disruptionfeature is upstream or downstream of the pressure sensor. Pressure datameasured by pressure sensor 4804 is communicated to the controller (notshown) via connector 4806. This turbulence inducer can be included onthe stylet and deployed much like an umbrella and then retracted. Thisturbulence inducer can be deployed and pushed through the vasculature asthe device approaches the heart, or the turbulence inducer could bedeployed at specific times when the location of the device needs to bedetermined. This could either be at a predetermined intervals, forexample, about every 3 seconds (or ranging from 1 second to 5 seconds)or simply deployed whenever the operator would like to take ameasurement. Alternatively, the turbulence inducer may be small enoughso that it may be permanently deployed.

FIG. 50 shows an embodiment which includes controller 114 and a mediumintroduction mechanism 5002 controlled by the controller via lever ormechanism 5004. The medium introduction mechanism may be a syringecontaining saline or other fluid and mechanism 5004 may be a levercontrolled by a motor within the controller. Alternatively, thecontroller may be remote from the medium introduction mechanism. Themedia introduction mechanism may alternatively be manually driven. Thecontroller may be at the patient's bedside or remote. The controller mayprovide real time feedback if there are any changes of safety issues. Itmay be used standard PICC, subclavian, and intra jugular catheters,central catheters, regardless of brand.

Controller

The controller may control delivery of the medium and detection of themedium parameter in the blood flow. In addition the controller willreceive information from the one or more sensors and interpret theinformation to assess the location, relative location, and/or hazardzones within the vasculature. The sensor signals are communicated, via awire, fiber optic cable, or other means, back to the controller wherethe signal(s) are analyzed based on the measured parameter, parameterprofile, parameter of more than one sensor, or change in parameter overtime and/or distance. For example, the controller can determine whetherthe distal end of the vascular catheter navigation device is in anartery instead of a vein, based on magnitude and direction of bloodflow, and/or other flow parameters, near the vascular catheternavigation device. For example, if the controller determines that thedistal end of the vascular catheter navigation device is in an arteryinstead of a vein, a specific identifying signal may sound, including anaudible, visual signal etc., instructing the user to remove the vascularcatheter navigation device, and any other device, such as sheaths,catheters etc., and apply pressure to the blood vessel. For example,instructions for advancing, retreating, redirecting, stopping orremoving, the vascular catheter navigation device may be displayed bythe controller on a screen connected to the controller either. Theconnection may be wired or wireless and the screen may be local orremote. The signal from the controller may be transmitted overBluetooth, or other wireless protocol, to a computer such as a laptop,tablet, phone, watch, or other peripheral device.

The controller may control introduction of medium, including injectionof a temperature controlled solution, such as saline, introduction ofsound, introduction of light etc. Temperature controlled may mean atemperature which is different than body temperature.

The controller may also integrate with other system, such as electronicmedical systems, electronic health systems etc. The integration may bewired or wireless and may be local or remote. The integration may be via“EMR sniffers”.

Injection Mechanism and Fluid Properties

The infusion drip, bolus, droplet, stream, etc., used to detect catheterlocation may have specific parameters. The infusion may be a drip or itmay be a stream. The preferred intermittent volume size (drip, drop,bolus, intermittent stream) is between about 0.5 cc to about 3 cc, butcan range between about 0.1 cc and about 10 cc. Alternatively the volumemay range from about 0.5 cc to about 1 cc. Alternatively the volume mayrange from about 0.5 cc to about 2 cc.

The preferred drip interval may be between about every 0.5 second toabout every 4 seconds to a broader range of about every 0.25 seconds toabout every 10 seconds. Where the infusion is a continuous stream, thepreferred flow rate is about 4 cc/minute but may range from about 0.25cc/minute to about 15 cc/minute or from about 0.1 cc/minute to about 30cc/minute or from about 0.1 cc/minute to about 60 cc/minute.

The pressure applied to the injection mechanism (syringe, for example)for injection may be around 3 psi but may range from about 1 psi toabout 5 psi, or the range may be from about 0.1 psi to around 200 psi.

The fluid temperature in a thermo-dilution sensing solution is optimallyaround 22.5 C but may be about 20 C to about 25 C or from about 1 C toabout 36 C. Alternatively the fluid may be greater than bodytemperature, optimally about 40 C but ranging from about 39 C to 42 C orabout 37 C to about 45 C.

The controller may control an injection device, or volumetric displacingdevice, such as a syringe, so that the injection device introduces acontrolled volume and/or rate of fluid into the catheter orstylet/guidewire. The fixed volume and/or rate of fluid may be at acontrolled temperature, either above or below that of blood(approximately 37 degrees Celsius), or at a known temperature which ismeasured. The injection device may inject a controlled volume and/orrate of fluid at predetermined intervals, or other intervals, orcontinuously. The controlled volume and/or rate of fluid may remain thesame throughout a procedure, or the volume and/or rate may changedepending on the patient, the location of the catheter/system within thevasculature, etc. For example, the volume and/or rate of fluid injectedmay increase as the tip of the catheter gets closer to the heart. Thevolume and/or rate may be different for different sized vascularcatheters or different sized lumens of vascular catheters, for examplein catheters with multiple lumens.

The volume and/or rate of fluid injected may be controlled by a leadscrew, cam, linear actuator motor etc. The force of the injectionrequirements may also be controlled and/or monitored. For example, if anunusually high force is required to inject the fluid, an alert may tellthe user that a possible catheter blockage situation exists, including acatheter kink, a blood clot, the catheter tip up against a vessel wall,or within a small vessel, or other catheter patency situation. Higher orlower force injections may be used in different areas of the anatomy, orto confirm location within the anatomy. For example, a higher forcedinjection of a smaller volume and/or rate may provide differenttemperature curve information than a lower force, higher volume and/orrate injection. Small volume injections at a higher frequency mayprovide different information than larger volume injections at a lowerfrequency, etc.

The fluid injector may also be configured to withdraw fluid through thecatheter/stylet/guidewire to determine injection lumen/tip patency. Thecontroller may assess force to withdraw fluid to determine that fluid isflowing freely through the catheter/stylet/guidewire. If fluid is notflowing freely, a patency alert may alert the user. Alternatively thecontroller may have a sensor which senses the existence of blood in thesystem when the injector withdraws fluid through thecatheter/stylet/guidewire. This may be done optically or otherwise.

An embodiment of the injection mechanism is shown in FIG. 51. Thisembodiment may include an automated injection system for thecartridge/syringe/reservoir which may be a motor driving lead screw. Thecontroller controls the infusion delivery parameters, includingpressure, volume, frequency, rate, etc. The controller may also controlthe GUI. The buttons, shown in FIG. 51 may turn the device on and off,purge the catheter of air prior to insertion, and/or may stop operationof the device in case of a sensed problem situation. The unit may befully disposable, partially disposable or non-disposable, and may residein the sterile field or the unsterile field during the procedure.

The system may come packaged with a prefilled injection device, or afillable injection device. Saline may be used as the fluid. Contrastmedium may be used (which is a higher viscosity than saline). Fluids ofdiffering viscosity may be used, or fluids may be mixed (such ascontrast medium and saline) to achieve a desired viscosity or otherdesired properties. Fluids of different surface tension, differentspecific heat capacity, different acidity or other different attributesmay be used. Fluids with properties that differ from those of blood willprovide different temperature curves and therefor provide differentinformation regarding the location of the catheter/guidewire/stylet tipin the vasculature. Some fluids may be soluble in blood and others lesssoluble. Since the injection fluid is injected into the blood stream,the fluid used will preferably be biocompatible.

Additives may be added to the injection fluid for different results. Forexample, salts, such as NaCl may be added. Different salts or otheradditives may improve an ECG signal in embodiments that include an ECGelectrode. A different fluid (liquid or gas) may be introduced with theprimary fluid to modify the fluid properties. For example, abiocompatible liquid or gas may be “bubbled” into saline.

A user interface controlled by the controller may include a display,alerts (auditory, visible, lights, vibrations etc.) and otherinformation. The user interface may include a display of the anatomywith a virtual reality indicator of the location of thecatheter/guidewire/stylet tip within the anatomy. For example, thedisplay may be an image of the human vascular system, and a movingindicator, such as a light, may show where within the anatomy thecatheter/guidewire/stylet tip is. The display may be actual size, andpossibly even projected upon the patient, or it may be a smaller orlarger size, for example, displayed on the controller, a tablet, orprojected up on the wall. The controller and/or display may include acomputer, laptop, tablet, mobile phone, virtual reality/augmentedreality glasses, etc.

The system may be fully disposable. A fully disposable system primarypackage includes: syringe, syringe pump, the syringe filled with thefluid of choice, a controller, a user interface which can exist as anycombination of display, alert, and lights, catheter, stylet/guidewire,and introduction mechanism. All of these elements may be fullydisposable. By doing so, the chance of infection will be reduced.

Another embodiment includes all of the items listed above where thedisplay is non-disposable. The display may be within the non-sterilefield and communicate via cable or a wireless communications protocolsuch as Bluetooth. Alternatively, the display may be within the sterilefield using a wired or wireless connection. Additionally/alternatively,the display may be projected on glasses—either virtual reality oraugmented reality glasses. The glasses may be within the sterile ornon-sterile field. Additionally, a projector may project the display ona surface of choice and the projector may be in sterile or non-sterilefield.

Another embodiment consists of two subsystems. The disposable elementsmay include catheter, stylet/guidewire, and a fluid filled volumedisplacing device, such as a syringe. The non-disposable elements mayinclude a controller in a housing, mechanics/motors to depress the leadscrew on the syringe/cartridge, display, audio, and visual elements, aswell as user interaction buttons, etc.

Any of the catheter/stylet/guidewire placement and/or patency techniquesdisclosed herein may be used while placing the device in thevasculature, as well as after placement, to determine that the devicehas not significantly strayed from its placement location.

Any of the embodiments disclosed herein may be used with any type ofcentral vascular catheter including Central Venus lines, Clavicle lines,midline, etc. In addition, any of the embodiments disclosed herein maybe used with peripheral vascular catheters, dialysis catheters, andcardiac catheters including catheters used for: coronary arteries,patent foramen ovale, atrial septal defect, etc. Any of the embodimentsdisclosed herein may be used with any type of urinary catheters. Similartechnology may be used in underwater navigation, mining, oil and gasexportation, utility fabrication or repair, transportationinfrastructure fabrication and repair, etc.

Other technologies may also be used in conjunction with the sensorreadings from the vascular catheter. For example ECG readings,ultrasound readings, Doppler readings, x-ray readings, inductive currenttechnology, pressure readings, etc. Some, all or no readings may beaugmented via a turbulence inducer. These, and other, other types ofreadings may be used in conjunction with the sensor readings by thecontroller to determine the location of the vascular catheter navigationdevice distal tip. Specific modalities may be better at identifyingspecific vascular landmarks or conditions.

For example, any of the conductive components of the vascular navigationdevice may be used as an ECG lead. Another ECG lead may be placed on thepatient's skin. For example, the guidewire stylet stiffener, coil,enclosure, thermocouple leads, sensor leads, thermocouple, endcap,conduit, etc. may be used as an ECG lead. Alternatively, a separate ECGlead may be added to the system.

Embodiments of the vascular navigation device may include the ability tomeasure cardiac output. The temperature vs. time curve may be analyzedby the controller to determine cardiac output in addition to vascularlocation, either simultaneously, or at separate times. Cardiac outputmay also be used to help establish the location of the vascularnavigation device within the vasculature.

Several embodiments have been disclosed herein. It will be understoodthat any of the features of any of the embodiments may be combined withany embodiment.

Some embodiments of the vascular access or vascular navigation devicemay be used in other applications. For example, the controller of thedevice may be equipped with logic to navigate, identify, and assess thehealth of various vascular or other anatomies. For example, someembodiments may be configured to identify the location of valves withinthe peripheral vascular (for example, venous) system. Valve location maybe identified based on the flow characteristics near and within a valve.Valve health may be assessed based on flow characteristics near andwithin a valve. Valve function may be assessed based on flowcharacteristics near and within a valve. Valve closure may be assessedbased on flow characteristics near and within a valve. Vascular flowcharacteristics may be used by the system to navigate near to, within,and/or past valves. Some embodiments of the vascular navigation devicemay be used in conjunction with treatment procedures. For example, thesystem may be used to aid in placement of valve prosthetics, valverepair etc. The system may be used to assess the success of suchprocedures, based on flow characteristics, placement location etc. Thesystem may also be used to navigate to vessel stenting locations, and toassess the function of a vessel before and after a procedure. The systemmay be used to assess the function and/or location and/or health of aprosthetic (stent, valve etc.) before and after its placement.

In some embodiments, the system may be used to diagnose a stenosis,blockage, narrowings or disease of a blood vessel based on flowcharacteristics. The system may be used to classify a stenosis,blockage, narrowings or disease of a blood vessel based on flowcharacteristics. The system may be used to identify the location andquantity of spinal fluid leak.

In some embodiments of the system, the vascular system is accessedperipherally, via a leg, arm, groin, etc.

Some embodiments of the system may be used to diagnose other diseases orhealth based on flow characteristics of vessels or other organs (such asthe bladder, lungs, etc.)

Some embodiments of the system may be used to assess health of, andnavigate through, other vessels such as those in the brain. For example,the system may be used to identify, navigate to and assess the healthof, aneurysms, blockages, narrowings, stenosis with the brain andelsewhere in the body.

Embodiments of the system may be used for any interventional radiologyprocedure including Angiography, Arteriovenous Malformations (AVM),Balloon Angioplasty, Biliary Drainage and Stenting, Bleeding Internally,Central Venous Access, Chemoembolization, Embolization, GastrostomyTube, Hemodialysis Access Maintenance, High Blood Pressure, Infectionand Abscess Drainage, Needle Biopsy, Radiofrequency Ablation, Stent,Stent Graft, Thrombolysis, TIPS (Transjugular Intrahepatic PortosystemicShunt), Urinary Tract Obstruction, Uterine Artery Embolization, UterineFibroid Embolization, Varicocele Embolization, Varicose Vein Treatment,Vena Cava Filter, Vertebroplasty, Deep Vein Thrombosis, etc.

Some embodiments of the system may be used to identify blood flowdirection, speed, flow characteristics, etc. This may be useful not onlyfor navigation of the venous system, but also in assessing venous orarterial flow conditions that are useful for identifying heart disease,chronic venous disorder, venous outflow obstructions, etc.

Some embodiments of the system may be used to identify the change inflow characteristics of the blood as it responds to drugs such bloodthinners (heparin, etc.) acutely or over time. For example, bloodthinness, viscosity, or other properties may be assessed based on theflow characteristics.

Some embodiments of the multi sensor technology may also be included ina permanent implant within the body rather than used as a temporarydevice. It may be used to measure the performance or health of thecardiovascular system over time, measure post intervention performanceover time, etc. This type of intervention may be surgical only, such aswhen used in a bypass procedure, and may also include monitoring theresults and/or performance, and/or success of interventions such asmechanical valves, stents, balloons, etc. It may also be used for theassessment of the need for interventions.

In another embodiment, in addition to or instead of measuringtemperature of a fluid bolus or stream that is injected, the system maymeasure the electrical conductivity of a bolus or stream of fluid. As astream or bolus of fluid fluctuates with various flow conditions anddirections, variation in electrical conductivity can be detected.Additionally, fluid may be injected to optimize the electricalconductivity. For example, fluid containing one or more salts may beused to make the fluid more electrically conductive.

This technology may also be used outside of the body on the surface ofthe skin in proximity to one or more veins. This may be done on the skinor just under the skin, across the skin or within the skin. For example,the temperature sensors can be placed in several locations on top of theskin or vein. A heating or cooling event may be administeredintravascularly to detect blockages, flow, or navigation requirements.Conversely, the heating and or cooling event may happen externally tothe skin while the system senses the temperature intravascularly.Alternatively, pressure, or electrical conductivity may be used. Someembodiments may also detect flow characteristics, diagnose venous orarterial disease, challenges, and obstructions, in either acute orchronic events. Embodiments of the device on the surface of the body orvein may be a temporary assessment tool, or may be a more permanentlyworn biosensor such as a watch, ring, wristband, necklace, earing,contact lens, etc.

Example of Data Processing System

FIG. 52 is a block diagram of a data processing system, which may beused with any embodiment of the invention. For example, the system 5200may be used as part of the controller. Note that while FIG. 52illustrates various components of a computer system, it is not intendedto represent any particular architecture or manner of interconnectingthe components; as such details are not germane to the presentinvention. It will also be appreciated that network computers, handheldcomputers, mobile devices, tablets, cell phones and other dataprocessing systems which have fewer components or perhaps morecomponents may also be used with the present invention.

As shown in FIG. 52, the computer system 5200, which is a form of a dataprocessing system, includes a bus or interconnect 5202 which is coupledto one or more microprocessors 5203 and a ROM 5207, a volatile RAM 5205,and a non-volatile memory 5206. The microprocessor 5203 is coupled tocache memory 5204. The bus 5202 interconnects these various componentstogether and also interconnects these components 5203, 5207, 5205, and5206 to a display controller and display device 5208, as well as toinput/output (I/O) devices 5210, which may be mice, keyboards, modems,network interfaces, printers, and other devices which are well-known inthe art.

Typically, the input/output devices 5210 are coupled to the systemthrough input/output controllers 5209. The volatile RAM 5205 istypically implemented as dynamic RAM (DRAM) which requires powercontinuously in order to refresh or maintain the data in the memory. Thenon-volatile memory 5206 is typically a magnetic hard drive, a magneticoptical drive, an optical drive, or a DVD RAM or other type of memorysystem which maintains data even after power is removed from the system.Typically, the non-volatile memory will also be a random access memory,although this is not required.

While FIG. 52 shows that the non-volatile memory is a local devicecoupled directly to the rest of the components in the data processingsystem, the present invention may utilize a non-volatile memory which isremote from the system; such as, a network storage device which iscoupled to the data processing system through a network interface suchas a modem or Ethernet interface. The bus 5202 may include one or morebuses connected to each other through various bridges, controllers,and/or adapters, as is well-known in the art. In one embodiment, the I/Ocontroller 5209 includes a USB (Universal Serial Bus) adapter forcontrolling USB peripherals. Alternatively, I/O controller 5209 mayinclude IEEE-1394 adapter, also known as FireWire adapter, forcontrolling FireWire devices, SPI (serial peripheral interface), I2C(inter-integrated circuit) or UART (universal asynchronousreceiver/transmitter), or any other suitable technology. Wirelesscommunication protocols may include Wi-Fi, Bluetooth, ZigBee,near-field, cellular and other protocols.

Some portions of the preceding detailed descriptions have been presentedin terms of algorithms and symbolic representations of operations ondata bits within a computer memory. These algorithmic descriptions andrepresentations are the ways used by those skilled in the dataprocessing arts to most effectively convey the substance of their workto others skilled in the art. An algorithm is here, and generally,conceived to be a self-consistent sequence of operations leading to adesired result. The operations are those requiring physicalmanipulations of physical quantities.

It should be borne in mind, however, that all of these and similar termsare to be associated with the appropriate physical quantities and aremerely convenient labels applied to these quantities. Unlessspecifically stated otherwise as apparent from the above discussion, itis appreciated that throughout the description, discussions utilizingterms such as those set forth in the claims below, refer to the actionand processes of a computer system, or similar electronic computingdevice, that manipulates and transforms data represented as physical(electronic) quantities within the computer system's registers andmemories into other data similarly represented as physical quantitieswithin the computer system memories or registers or other suchinformation storage, transmission or display devices.

The techniques shown in the Figures can be implemented using code anddata stored and executed on one or more electronic devices. Suchelectronic devices store and communicate (internally and/or with otherelectronic devices over a network) code and data using computer-readablemedia, such as non-transitory computer-readable storage media (e.g.,magnetic disks; optical disks; random access memory; read only memory;flash memory devices; phase-change memory) and transitorycomputer-readable transmission media (e.g., electrical, optical,acoustical or other form of propagated signals—such as carrier waves,infrared signals, digital signals).

The processes or methods depicted in the preceding Figs may be performedby processing logic that comprises hardware (e.g. circuitry, dedicatedlogic, etc.), firmware, software (e.g., embodied on a non-transitorycomputer readable medium), or a combination of both. Although theprocesses or methods are described above in terms of some sequentialoperations, it should be appreciated that some of the operationsdescribed may be performed in a different order. Moreover, someoperations may be performed in parallel rather than sequentially.

What is claimed is:
 1. A location detection system, comprising: anelongate body; a conduit defining one or more flow passages, where eachof the one or more flow passages has a distal end and where the conduitis configured to secure a position of the elongate body relative to theconduit; a sensor positioned at or in proximity to the distal end of theelongate body, wherein the conduit maintains a fixed distance betweenthe sensor and the one or more flow passage distal ends, and wherein thesensor is configured to measure at least one parameter of a fluid afterthe fluid is emitted from the one or more flow passage distal ends; anda controller in communication with the sensor, wherein the controller isconfigured to determine a time-derived function of the at least oneparameter of the fluid and is further configured to obtain a position ofthe sensor within a body of a subject, and wherein the time-derivedfunction is based upon a degree of turbulence of the fluid after emittedfrom the one or more flow passages.
 2. A method of determining alocation within a body of a subject, comprising: positioning an elongatebody within a lumen of a catheter; positioning the catheter within thebody of the subject; introducing a fluid through the lumen and one ormore flow passages of a conduit into the body; measuring via a sensor atleast one parameter of the fluid after introduction within the body ofthe subject, wherein the sensor is positioned at or in proximity to adistal end of the elongate body such that the sensor is maintained at afixed distance relative to a fluid exit port of the catheter or conduit;determining a time-derived function of the at least one parameter of thefluid; and determining a position of the sensor within the body of thesubject based upon the time-derived function.
 3. The method of claim 2wherein positioning the catheter comprises advancing the catheterintravascularly within the body of the subject.
 4. The method of claim 2wherein measuring via a sensor at least one parameter comprisesmeasuring a temperature.
 5. The method of claim 2 wherein introducing afluid further comprises passing the fluid through the one or more flowpassages of the conduit positioned at or in proximity to the distal endof the elongate body.
 6. The method of claim 2 wherein the elongate bodyis attached to the conduit.
 7. The method of claim 2 wherein theelongate body is positioned to extend longitudinally relative to thelumen.
 8. The method of claim 2 further comprising measuring anelectrical signal within the body via an ECG electrode incorporated intothe elongate body.
 9. The method of claim 2 wherein measuring via asensor further comprises transmitting sensor data between the sensor anda controller.
 10. The method of claim 9 further comprising transmittingtemperature data between the sensor and the controller.
 11. The systemof claim 2 wherein determining a time-derived function comprisesdetermining a degree of turbulence of the fluid after being emitted fromthe fluid exit port.
 12. The method of claim 2 wherein determining atime-derived function comprises determining a difference in temperaturefrom baseline to obtain the position of the sensor within the body. 13.A location detection system for use within a catheter lumen, comprising:an elongate body; a sensor positioned at or in proximity to the distalend of the elongate body, wherein the sensor is configured to measure atleast one parameter of a fluid after the fluid is emitted from thecatheter lumen; and a controller in communication with the sensor,wherein the controller is configured to determine a time-derivedfunction of the at least one parameter of the fluid and is furtherconfigured to obtain a position of the sensor within a body of a subjectbased upon the time-derived function.
 14. The system of claim 13 furthercomprising a catheter which defines the catheter lumen.
 15. The systemof claim 13 wherein the elongate body comprises a stylet.
 16. The systemof claim 13 wherein the elongate body comprises a guidewire.
 17. Thesystem of claim 13 wherein the sensor is positioned at or distal to anopening of the catheter lumen.
 18. The system of claim 13 wherein thesensor is positioned at the distal end of the elongate body.
 19. Thesystem of claim 13 wherein the sensor comprises a temperature sensor.20. The system of claim 13 further comprising a conduit positioned atleast partially within the catheter lumen.
 21. The system of claim 20wherein the elongate body is attached to the conduit.
 22. The system ofclaim 13 wherein the sensor is positioned along a longitudinal axis ofthe catheter lumen.
 23. The system of claim 13 wherein the sensor ispositioned at a fixed distance relative to an opening of the catheterlumen.
 24. The system of claim 13 further comprising an ECG electrodeincorporated into the elongate body.
 25. The system of claim 13 furthercomprising a pressure sensor incorporated into the elongate body. 26.The system of claim 13 further comprising a fluid reservoir incommunication with the catheter lumen.
 27. The system of claim 13wherein sensor data is transmitted between the sensor and thecontroller.
 28. The system of claim 27 wherein the sensor data comprisestemperature data.
 29. The system of claim 28 wherein the controller isconfigured to obtain a position of the sensor within a vasculature ofthe body of the subject based upon the temperature data.
 30. The systemof claim 13 wherein the time-derived function is based upon a degree ofturbulence of the fluid after emitted from an opening of the catheterlumen.